Hazelo Lab Pvt. LTD., Yadadri Bhuvanagiri District - Draft EIA Report (Part I) PDF

HAZELO LAB PVT. LTD.

SY.NO. 240, 242, 243, 247, 248 AND 249, DOTHIGUDEM VILLAGE,
POCHAMPALLY MANDAL, YADRADI BHUVANAGIRI DISTRICT,
TELANGANA

DRAFT EIA REPORT

1. ENVIRONMENTAL IMPACT ASSESSMENT
2. ENVIRONMENT MANAGEMENT PLAN
3. COMPLIANCE OF TERMS OF REFERENCE
4. ANNEXURES

Project No. 0317‐21‐01
March 2017
STUDIES AND DOCUMENTATION BY
Hazelo Lab Pvt. Ltd. TEAM Labs and Consultants
Hetero Corporate Office, 7‐2‐A2, Industrial Estate B‐115‐117 & 509, Annapurna Block,
Sanath Nagar, Hyderabad, Aditya Enclave, Ameerpet,
Telanagana – 500 018 Hyderabad‐500 038.
Phone: 08455‐233585 Fax: 08455‐233840 Phone: 040‐23748 555/23748616,
E‐mail: ratnakarreddy@heterodrugs.com Telefax: 040‐23748666

SUBMITTED TO
TELANGANA STATE POLLUTION CONTROL BOARD,
REGIONAL OFFICE, NALGONDA
HAZELO LAB PVT. LTD.
SY.NO. 240, 242, 243, 247, 248 AND 249, DOTHIGUDEM VILLAGE,
POCHAMPALLY MANDAL, YADRADI BHUVANAGIRI DISTRICT,
TELANGANA

1. ENVIRONMENTAL IMPACT ASSESSMENT REPORT

Project No. 0317‐21‐01
March 2017
STUDIES AND DOCUMENTATION BY
Hazelo Lab Pvt. Ltd. TEAM Labs and Consultants
Hetero Corporate Office, 7‐2‐A2, Industrial Estate B‐115‐117 & 509, Annapurna Block,
Sanath Nagar, Hyderabad, Aditya Enclave, Ameerpet,
Telanagana – 500 018 Hyderabad‐500 038.
Phone: 08455‐233585 Fax: 08455‐233840 Phone: 040‐23748 555/23748616,
E‐mail: ratnakarreddy@heterodrugs.com Telefax: 040‐23748666

SUBMITTED TO
TELANGANA STATE POLLUTION CONTROL BOARD,
REGIONAL OFFICE, NALGONDA
Hazelo Lab Pvt. Ltd.

Declaration by Experts Contributing to the EIA
I, hereby, certify that I was a part of the EIA team in the following capacity that developed
the above EIA.
EIA coordinator:
Name: G.V. Reddy
Signature and Date: November 9, 2016
Period of involvement: October 2015 to till date
Contact information: Team Labs and Consultants, B115 - 117, 509, Aditya Enclave,
Ameerpet, Hyderabad 500038.
Functional area experts:

S. Functional Name of the Involvement Signature and
No. areas expert/s (period and task**) date
Period of involvement : Feb xxx till date March 15, 2017
1 AP T.Ravi kiran Site visit, Design of AAQ network,
supervision of AAQ monitoring,
Compilation of emissions and
characteristics, assessment of impacts
due to the proposed expansion,
identification of mitigation measures,
preparation of EMP for AP, Preparation
of monitoring plan for AP.
2 WP G.V.Reddy Site visit, identification of monitoring
stations, supervision of sampling,
Characterization of effluent streams,
segregation of effluent streams, ZLD for
effluent treatment, assessment of impacts
due to the proposed expansion,
preparation of EMP for WP, Preparation
of monitoring plan for WP.
3 SHW G.V.Reddy Site visit, Characterization of solid
wastes, storage, and disposal plan for
various solid wastes, assessment of
impacts due to the proposed expansion,
preparation of EMP for SHW.
Team Labs and consultants


4 SE K. Nanaji Site visit, primmary and seecondary data d

collecction of thee impact area, assessm ment
of im
mpacts due to the exp pansion pro oject
on socio
s econo omic status and pro oject
econo omy, prep paration ofo CSR p plan,
Prepaaration of SSE part of EIIA report.
5 EB I. Sivarrama Site visit, prim
mary and seecondary datad
Krishna collecction relaated to ecology aand
biodiiversity, aassessment of impaacts
basedd on IAIA guidelines,
g preparation
n of
mitig
gation meeasures, prreparation of
greenn belt plan and cost c estim
mate,
prepaaration of E
EB part of EIA report.
6 HG G.V.A. Identtification off water sheeds of the aarea
Ramakrish
hna by preparing the drrainage m map,
assesssment of gground watter potentiaal of
the site
s and imp pact area, preparation n of
rain water
w harveesting plan,, assessmen
nt of
impaacts due to ground waater abstracttion
and mitigation
m m
measures.
7 SC D. Sundar Rao Identtification off soil samppling locatiions
and characterrization of the so oils,
interppretation oof soil anaalysis repo orts,
assesssment of iimpacts du ue to spillag ges,
acciddental releasses of chem
micals, efflueents
etc., and
a mitigattion measurres.
8 AQ M. Srinivassa Assissting AP FAAE in identifying the A AAQ
Reddy moniitoring statiions by prooviding normal
climaatological and
a other historical
h d
data,
Identtification of Microm meteorolog gical
data monitoring g station, supervision
s n of
met data colleection usin ng Autom matic
weatther station,, Preparatio
on of emisssion
detaiils, Air quality
q imp
pact predicttion
modeeling, Callculation of o work ro oom
conceentrations of solven nts using box
modeel, Assessment off results aand
prepaaration of isopleths, asssisting the AP
FAE and EIA co oordinator in preparattion
of EM
MP.
9 LU G.V.A. Prepaaration of land
l use laand cover m
map
Ramakrish
hna using
g satellite imagery, ground trruth
study
y, assessinng the im mpacts due to
expannsion. Prep
paration of FAE
F report.
Team Labs and

a consultaants


10 RH D. Sadasivudu Site visit, assessment of hazop reports,

identification of sources of hazards,
assessment of storages proposed in
comparison with statutory regulations
and calculation of FETI to assess the
scope of risk assessment, preparation of
isopleths for various scenarios as part of
consequence analysis, identification of
mitigation measures preparation of
disaster management plan.
Declaration by the Head of the accredited consultant organization/ authorized person

I, G.V. Reddy hereby, confirm that the above mentioned experts prepared the EIA
report for M/s. Hazelo Lab Pvt. Ltd. I also confirm that the consultant organization shall be
fully accountable for any mis-leading information mentioned in this statement.
Signature:
Name: G.V. Reddy

Designation: Director
Name of the EIA consultant organization: Team Labs And Consultants
NABET Certificate No: S. No. 148 of List ‘A’ – Accredited EIA Consultant Organizations
complying with Version 3 of the Scheme - as on Rev. 51 March 07, 2017
Team Labs and consultants

Scheme for Accreditation of EIA Consultant Organizations
Scope of Accreditation
As per NABET Scheme Project or Activity as
per Schedule of
S. No. Consultant Organization MoEFCC Notification
Sector
Name of Sector Category dated September 14,
Number
2006 and subsequent
Amendments
Jaipur,Rajasthan-3020022
Common effluent treatment plants
36 B 7(h)
e. mail: eia@teamtesthouse.com (CETPs)
Tel.: 0141-2369980
**Though the EIA Coordinator for this sector was 38 Building and construction projects B 8 (a)
found suitable for Cat. A, the organization as a
whole was accredited for Cat. B, in view of their
having scored less than 60% marks in Office
Assessment. They can take up projects in this sector
only for Cat. B as an organization.
Townships and Area development
39 B 8 (b)
projects
Conditions apply
TEAM Labs and Consultants Mining of minerals including Open

1 A 1 (a) (i)
cast / Underground mining
Address: B- 115 & 509, Annapurna Block, Aditya 4 Thermal power plants A 1 (d)
Enclave, Ameerpet, Hyderabad ʹ 500038 Metallurgical industries (ferrous
8 A 3 (a)
148 only) ʹ both primary and secondary
e. mail:teamlabs@gmail.com 9 Cement plants A 3 (b)
13 Chlor-alkali industry A 4 (d)
Tel.: 040 ʹ 23748666/ 23748616 Pesticides industry and pesticide
09866415966 17 A 5 (b)
specific intermediates (excluding
List of Accredited Consultant Organizations (Alphabetically) Rev. 51 March 07, 2017 Page 123
Scheme for Accreditation of EIA Consultant Organizations
Scope of Accreditation
As per NABET Scheme Project or Activity as
per Schedule of
S. No. Consultant Organization MoEFCC Notification
Sector
Name of Sector Category dated September 14,
Number
2006 and subsequent
Amendments
formulations)
Conditions apply Synthetic organic chemicals industry
(dyes & dye intermediates; bulk
drugs and intermediates excluding
21 drug formulations; synthetic A 5 (f)
rubbers; basic organic chemicals,
other synthetic organic chemicals
and chemical intermediates)
Industrial estates/ parks/
complexes/Areas, export processing
31 Zones(EPZs), Special economic A 7 (c)
zones(SEZs), Biotech Parks, Leather
Complexes
34 Highways A 7 (f)
38 Building and construction projects B 8(a)
Townships and Area development
39 B 8 (b)
projects
Terracon Ecotech Pvt. Ltd. 1 Mining of minerals- Open cast only B 1 (a) (i)
Off shore and on shore oil and gas
Address: 202, Kingston, Tejpal Road, Vile Parle (E), 2 exploration, development and A 1(b)
Mumbai 400057, India production
149
River valley, hydel, drainage and
3 B 1 (c)
e. mail:info@terraconindia.com irrigation projects
Oil & gas transportation pipeline
27 A 6 (a)
Tel.:022-2613939/40/41, 9820828087 (crude and refinery/ petrochemical
List of Accredited Consultant Organizations (Alphabetically) Rev. 51 March 07, 2017 Page 124
Hazelo Lab Pvt. Ltd., Contents
CONTENTS
Section Description Page No.
Declaration by Experts Contributing to the EIA
E.0 Executive Summary 1-1
1.0 Introduction of The Project 1-1

1.1 Product Profile 1-3
1.2 Technology 1-5
1.3 Plant Location & Layout 1-5
1.4 Scope of EIA Studies 1-8
2 Process Description and Pollution control Facilities 2-1
2.1 Process Description 2-3
2.1.1 Process Description of Amlodipine Besylate 2-3
2.1.2 Process Description of Bupropion HCl 2-5
2.1.3 Process Description of Clopidogrel Hydrogen Sulfate 2-8
2.1.4 Process Description of Desvelofloxin Succinate 2-11
2.1.5 Process Description of Divolproex Sodium 2-14
2.1.6 Process Description of Dulaxetine HCl 2-16
2.1.7 Process Description of Esomeprazole Mg Dihydrate 2-18
2.1.8 Process Description of Glimepiride 2-20
2.1.9 Process Description of Mesalamine 2-22
2.1.10 Process Description of Metaprolol Succinate 2-23
2.1.11 Process Description of Pantoprazole Sodium Sesquihydrate 2-27
2.1.12 Process Description of Pragabalin 2-29
2.1.13 Process Description of Rosuvastatin Calcium 2-30
2.1.14 Process Description of Sertraline HCl 2-33
2.1.15 Process Description of Tramadal 2-35
2.1.16 Process Description of Valcyclovir Hydrochloride Monohydrate 2-37
2.1.17 Process Description of 4-[4-Chloro-1-oxobutyl]-2,2- dimethyl phenyl acetic acid 2-41
methyl ester
2.1.18 Process Description of N2-(1-(S)-ethoxy carbonyl-3-phenyl propyl-N6-trifluoro 2-47
acetyl-L-lysine
2.1.19 Process Description of 2-[2-[3(S)-[3-[2-(7-Chloro-2-Quinolinyl)-ethenyl]phenyl]- 2-50
3-hydroxypropyl]phenyl-2-propanol
2.1.20 Process Description of 2,8-Diazo bicyclo Nonane 2-55
2.1.21 Process Description of 2,3,4,5-Bis-O- (1- methylethylidene)-b-D-fructopyranose 2-61
2.1.22 Process Description of 2- Acetyl Ethoxy acetyl methoxy ether 2-63
2.1.23 Process Description of N,N-Carbonyl di imidazole 2-64
2.1.24 Process Description of (2S,3S,5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl 2-65
Amino 1,6-diohenyl
2.1.25 Process Description of Trans-4-(4-chlorophenyl)-cyclohexane carboxylic acid 2-70
2.1.26 Process Description of Guanine 2-73
2.1.27 Process Description of Poly allyl amine HCl 2-74
2.1.28 Process Description of Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4-flurophenyl)-6- 2-75
isopropyl-2-(N- methylmethane sulfonamido) Pyrimidin - 5-yl)vinyl)-2,2-
dimethyl-1,3-dioxane-4-yl-) acetate
2.1.29 Process Description of 5-Cyano phthalide 2-80
2.1.30 Process Description of 1,1-Cyclohexanediacetic acid 2-83
2.1.31 Process Description of Carbamyl Methyl-5-Methyl hexanoic Acid 2-85
2.1.32 Process Description of 2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine 2-87
2.1.33 Process Description of N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine 2-91
amine
2.1.34 Process Description of 4-[(4-Methylpiperazin-1-yl)methyl]benzoic acid 2-94
dihydrochloride
2.1.35 Process Description of 2, 3-Epoxy-2-methyl-N-[4-cyano-3-(trifluoromethyl) 2-96
phenyl] propanamide
2.2 Utilities 2-100
2.3 Water Requirement 2-100
2.4 Pollution Control Facilities 2-101
2.4.1 Water Pollution 2-101
2.4.1.1 Process Description and Technical Specification of Effluent Treatment System 2-109
2.4.2 Air Pollution 2-116
2.4.2.1 Emissions from Utilities 2-116
2.4.2.2 Emissions from Process 2-118
2.4.2.3 Diffuse Emissions 2-121
2.4.2.4 Fugitive Emissions 2-121
2.4.2.5 Solvent Use and Recycle 2-121
2.4.3 Solid Waste 2-130
2.4.4 Noise Pollution 2-139
3.0 Baseline Environmental Status 3-1
3.1 Introduction 3-1
3.2 Land Environment 3-1
3.2.1 Physiography 3-1
3.2.2 Geology 3-3
3.2.3 Hydrogeology 3-3
3.2.4 Soils 3-4
3.3 Water environment 3-11
3.3.1 Surface Water Resources 3-11
3.3.1.1 Surface water Quality 3-11
3.3.2 Ground Water resources 3-13
3.3.2.1 Quality Of Ground Water 3-13
3.4 Air environment 3-19
3.4.1 Meteorology 3-19
3.4.2 Meteorological Station at Plant Site 3-22
3.4.3 Ambient air quality 3-25
3.4.4 Scope of field study 3-25
3.4.5 Description of sampling locations 3-27
3.4.6 Ambient Air Quality Status 3-29
3.5 Noise environment 3-30
3.6 Socio economic environment 3-33
3.6.1 Demography 3-33
3.6.1.1 Population Distribution 3-33
3.6.1.2 Literacy 3-34
3.6.1.3 Employment/Occupation 3-35
3.6.2 Living standards and Infrastructure 3-36
3.6.3 Land Utilization 3-38
3.6.4 Project Economy 3-39
3.7 Flora and Fauna 3-39
3.7.1 Land use and land cover of the study area 3-39
3.7.2 Land use and land cover of the plant site 3-40
3.7.3 Terrestrial Vegetation and Flora in the study area 3-40
3.7.4 Terrestrial Fauna 3-46
3.7.5 Aquatic Flora and Fauna 3-48
4 Identification of Impacts
4.1 Identification of Impacts 4-1
4.2 Impact Networks 4-1
4.2.1 Air Environment 4-1
4.2.2 Water Environment 4-2
4.2.3 Noise Environment 4-2
4.2.4 Land Environment 4-3
4.2.5 Biological Environment 4-3
4.2.6 Socio-Economic Environment 4-3
4.3 Prediction of Impact on Air Quality 4-10
4.3.1 Details of Mathematical Modeling 4-10
4.3.1.1 Model Formulation 4-11
4.3.1.2 Meteorological Data 4-12
4.3.2 Plant Emissions 4-13
4.3.2.1 Diffuse Emissions 4-16
4.3.2.2 Fugitive Emissions 4-16
4.3.2.3 Air Quality Predictions 4-16
4.3.2.4 Prediction of Concentration of Solvents in the Indoor Environment Due to 4-25
Solvent Loss and Fugitive Emissions
4.4 Prediction of Impact on Noise quality 4-26
4.5 Prediction of Impact on water quality 4-27
4.6 Prediction of Impact on soil 4-28
4.7 Prediction of Impact on Socio Economics 4-28
4.8 Impacts of the Industry on Flora and Fauna 4-28
4.9 Prediction of Impact on Vehicular Traffic 4-29
5 Environmental Monitoring 5-1
5.1.1 Introduction 5-1
5.1.2 Objectives 5-1
5.1.3 Methodology 5-1
5.1.4 Ambient Air Quality (AAQ) Monitoring 5-2
5.1.5 Water Quality Monitoring 5-3
5.1.6 Noise Level Monitoring 5-8
5.1.7 Responsibility of Monitoring and Reporting System 5-9
5.1.7.1 Work Zone Monitoring for Hazardous Chemicals 5-10
5.2 Environmental Monitoring Budget 5-10
6 Risk Assessment and Damage Control 6-1
6.0 Introduction 6-1
6.1 Objectives and Scope 6-1
6.2 Project Details 6-2
6.3 Process Description 6-10
6.4 Plant Facilities 6-10
6.4.1 Production Blocks 6-10
6.4.2 Utilities 6-10
6.4.3 Quality Control, R&D Lab 6-11
6.4.4 ETP and Solid Waste storage 6-11
6.4.5 Ware Houses 6-11
6.4.6 Tank Farm Area 6-12
6.4.7 Cylinders Storage Area 6-12
6.4.8 Administrative Office 6-12
6.4.9 Water Sump 6-12
6.4.10 House Keeping 6-12
6.4.11 Facility Layout and Design 6-12
6.5 Hazard Analysis and Risk Assessment 6-14
6.5.2 Hazard Identification 6-14
6.5.3 Fire & Explosion Index (F & EI) 6-18
6.5.3.1 Methodology 6-18
6.5.4 Hazard and Operability Study (HAZOP) 6-20
6.5.5 Hazard Factors 6-21
6.5.6 Common Causes of Accidents 6-24
6.6 Maximum Credible Accident and Consequence Analysis (MCACA) 6-26
6.6.1 Methodology 6-26
6.6.2 Identification of Vulnerable Areas 6-27
6.6.3 Representative Accident Scenarios 6-27
6.7 Consequence Analysis 6-28
6.7.1 Release Models and Source strength 6-29
6.7.2 Results of Consequence Analysis 6-31
6.7.2.1 Analysis of Hazardous Scenarios 6-32
6.7.2.1.1 Heat radiation effects 6-32
6.7.2.1.2 Toxic Dispersion 6-37
6.7.2.1.3 Overpressure effects 6-40
6.7.3 Observations 6-40
6.7.4 Recommendations 6-40
6.7.5 Toxic management plan 6-41
6.7.6 Transportation 6-43
6.7.7 Control measures for accidental spillage of chemicals 6-45
6.8 Disaster Management Plan 6-47
6.8.2 Objectives Of Emergency Management Plan (On-Site) 6-48
6.8.3 Scope Of ONSEP 6-49
6.8.4 Methodology Of Developing ONSET 6-49
6.8.5 Element Of ONSITE Emergency Plane 6-49
6.8.5.1 Emergencies Identified 6-50
6.8.5.2 Emergency Organization 6-50
6.8.5.3 Emergency Facilities 6-50
6.8.5.4 Emergency Procedures 6-53
6.8.5.5 Rescue and Rehabilitation 6-54
6.8.5.6 Emergency Responsibilities 6-55
6.8.6 Remedial Action 6-60
6.8.7 Basic Action In Emergencies 6-61
6.8.8 Fire Fighting Operations 6-61
List of Tables
S.No Description Page. No.
1.1 Manufacturing Capacity 1-3
2.1 Manufacturing Capacity Permitted 2-1
2.2 Manufacturing Capacity after Expansion 2-1
2.3 List of By-Product after Expansion 2-2
2.4 Material Balance of Amlodipine Besylate 2-4
2.5 Material Balance of Bupropion HCl 2-7
2.6 Material Balance of Clopidogrel Hydrogen Sulfate 2-10
2.7 Material Balance of Desvelofloxin Succinate 2-13
2.8 Material Balance of Divolproex Sodium 2-15
2.9 Material Balance of Dulaxetine HCl 2-17
2.10 Material Balance of Esomeprazole Mg Dihydrate 2-19
2.11 Material Balance of Glimepiride 2-21
2.12 Material Balance of Mesalamine 2-23
2.13 Material Balance of Metaprolol Succinate 2-26
2.14 Material Balance of Pantoprazole Sodium Sesquihydrate 2-28
2.15 Material Balance of Pragabalin 2-30
2.16 Material Balance of Rosuvastatin Calcium 2-32
2.17 Material Balance of Sertraline HCl 2-34
2.18 Material Balance of Tramadal 2-36
2.19 Material Balance of Valcyclovir Hydrochloride Monohydrate 2-39
Material Balance of 4-[4-Chloro-1-oxobutyl]-2,2- dimethyl phenyl acetic acid 2-45
2.20 methyl ester
Material Balance of N2-(1-(S)-ethoxy carbonyl-3-phenyl propyl-N6-trifluoro 2-49
2.21 acetyl-L-lysine
Material Balance of 2-[2-[3(S)-[3-[2-(7-Chloro-2-Quinolinyl)-ethenyl]phenyl]-3- 2-53
2.22 hydroxypropyl]phenyl-2-propanol
2.23 Material Balance of 2,8-Diazo bicyclo Nonane 2-59
2.24 Material Balance of 2,3,4,5-Bis-O- (1- methylethylidene)-b-D-fructopyranose 2-62
2.25 Material Balance of 2- Acetyl Ethoxy acetyl methoxy ether 2-63
2.26 Material Balance of N,N-Carbonyl di imidazole 2-64
2.27 Material Balance of (2S,3S,5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl Amino 2-68
1,6-diohenyl
2.28 Material Balance of Trans-4-(4-chlorophenyl)-cyclohexane carboxylic acid 2-72
2.29 Material Balance of Guanine 2-73
2.30 Material Balance of Poly allyl amine HCl 2-74
2.31 Material Balance of Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4-flurophenyl)-6-isopropyl- 2-78
2-(N- methylmethane sulfonamido) Pyrimidin - 5-yl)vinyl)-2,2-dimethyl-1,3-
dioxane-4-yl-) acetate
2.32 Material Balance of 5-Cyano phthalide 2-82
2.33 Material Balance of 1,1-Cyclohexanediacetic acid 2-84
2.34 Material Balance of Carbamyl Methyl-5-Methyl hexanoic Acid 2-86
2.35 Material Balance of 2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine 2-89
2.36 Material Balance of N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine 2-93
amine
2.37 Material Balance of 4-[(4-Methylpiperazin-1-yl)methyl]benzoic acid 2-95
dihydrochloride
2.38 Material Balance of 2, 3-Epoxy-2-methyl-N-[4-cyano-3-(trifluoromethyl) phenyl]
propanamide 2-98
2.39 List of Utilities 2-100
2.40 Total Water balance 2-100
2.41 Total Effluents generated and Mode of Treatment 2-101
2.42 Quantity and Characteristics of Process Effluents – Product Wise 2-102
2.43 Quantity and Characteristics of Process Effluents – Stage Wise 2-104
2.44 Details of Treatment Facilities 2-110
2.45 Technical Specifications of Effluent Treatment System 2-112
2.46 Technical Specifications of Biological Treatment Plant 2-113
2.47 Emission Details of Pollutants from Stack 2-116
2.48 Technical Specifications of Bag Filters 2-117
2.49 Quantity and Mode of Treatment of Process Emissions 2-118
2.50 Technical Specifications of Two Stage Scrubber 2-120
2.51 Total Solvent Balance – Product Wise 2-122
2.52 Total Solvent Balance – Stage Wise 2-124
2.53 Solid Wastes Generated from Process – Product Wise 2-131
2.54 Solid Waste Generated from Process – Stage Wise 2-133
2.55 Total Solid Waste Generated and Mode of Disposal 2-140
3.1 Soil Analysis Data 3-9
3.2 Soil Test Results – Reference Tables 3-10
3.3 Surface water Analysis 3-12
3.4 Locations of Ground water Sampling 3-13
3.5 Water Analysis Data 3-17
3.6 Meteorological data at IMD Station 3-20
3.7 Frequency Distribution of Wind Speeds and Wind Directions 3-23
3.8 National Ambient Air Quality Standards 3-26
3.9 Locations of Ambient Air Quality Monitoring Stations 3-27
3.10 Summary Ambient Air Quality Status 3-29
3.11 Effects on Human Beings at Different Noise Levels 3-31
3.12 Equivalent Noise levels in the Study Area 3-31
3.13 Population Distribution – Study Area 3-34
3.14 Literacy - Study Area 3-34
3.15 Employment - Study Area 3-35
3.16 Main workers study area 3-36
3.17 Land utilization Pattern 3-38
3.18 List of trees and shrubs found in the study area 3-41
3.19 Comparative list of the Weed flora in the study area 3-43
3.20 Check list of non woody plant species found in the buffer area 3-46
3.21 List of aquatic/semi aquatic macrophytes found in the study area 3-48
3.22 List of fishes either caught by the fisherman or reported from the study 3-49
4.1 Salient Features of the ISCST3 Model 4-11
4.2 Emission Details of Pollutants from Stack 4-14
4.3 Maximum Predicted 24 hourly GLC’s 4-17
4.4 Predicted GLC’s at Monitoring Locations 4-18
4.5 Cumulative Concentrations at Various Villages 4-19
4.6 Solvent Loss and the Predicted Airborne Concentrations 4-26
5.1 National Ambient Air Quality Standards 5-2
5.2 Indian Standard Drinking Water Specification-IS:10500:1991 5-4
5.3 Noise Level Standards (CPCB) 5-8
5.4 Environmental Monitoring Plan 5-8
5.5 Environmental Monitoring Budget 5-10
6.1 Proposed Manufacturing Capacity 6-3
6.2 List of By-Products – After Expansion 6-4
6.3 List of Raw Materials and Inventory 6-5
6.4 List of Utilities 6-11
6.5 Applicability of GOI Rules to Storage/Pipeline 6-16
6.6 Physical Properties of Raw Materials and Solvents 6-17
6.7 Degree of Hazard for F&EI 6-19
6.8 Fire & Explosion Index for Tank farm 6-19
6.9 Failure Rate Data 6-25
6.10 Ignition Sources of Major Fires 6-25
6.11 General Failure Frequencies 6-28
6.12 Damage Due to Incident Radiation Intensities 6-30
6.13 Radiation Exposure and Lethality 6-31
6.14 Damage Due to Peak Over Pressure 6-31
6.15 Heat Radiation Damage Distances – Tank Farm 6-32
6.16 Heat Radiation Damage Distances – Hydrogen Cylinders 6-37
6.17 Toxic Dispersion Damage Distance 6-38
6.18 List of Toxic/Carcinogenic chemicals and mode of Storage/Transport 6-41
6.19 Truck Incidents – Initiating and Contributing Causes 6-44
6.20 Transportation specific concerns 6-44
6.21 List of Fire Extinguishers 6-52
List of Figures
S.No Description Page. No.
1.1 Location of Location of M/s. Hazelo Lab Pvt. Ltd., 1-6
1.2 Plant Layout of Location of M/s. Hazelo Lab Pvt. Ltd., 1-7
2.1 Process Flow diagram of Amlodipine Besylate 2-3
2.2 Process Flow diagram of Bupropion HCl 2-6
2.3 Process Flow diagram of Clopidogrel Hydrogen Sulfate 2-9
2.4 Process Flow diagram of Desvelofloxin Succinate 2-12
2.5 Process Flow diagram of Divolproex Sodium 2-14
2.6 Process Flow diagram of Dulaxetine HCl 2-16
2.7 Process Flow diagram of Esomeprazole Mg Dihydrate 2-18
2.8 Process Flow diagram of Glimepiride 2-20
2.9 Process Flow diagram of Mesalamine 2-22
2.10 Process Flow diagram of Metaprolol Succinate 2-25
2.11 Process Flow diagram of Pantoprazole Sodium Sesquihydrate 2-27
2.12 Process Flow diagram of Pragabalin 2-29
2.13 Process Flow diagram of Rosuvastatin Calcium 2-31
2.14 Process Flow diagram of Sertraline HCl 2-33
2.15 Process Flow diagram of Tramadal 2-35
2.16 Process Flow diagram of Valcyclovir Hydrochloride Monohydrate 2-38
2.17 Process Flow diagram of 4-[4-Chloro-1-oxobutyl]-2,2- dimethyl phenyl acetic 2-43
acid methyl ester
2.18 Process Flow diagram of N2-(1-(S)-ethoxy carbonyl-3-phenyl propyl-N6- 2-48
trifluoro acetyl-L-lysine
2.19 Process Flow diagram of 2-[2-[3(S)-[3-[2-(7-Chloro-2-Quinolinyl)-
ethenyl]phenyl]-3-hydroxypropyl]phenyl-2-propanol 2-51
2.20 Process Flow diagram of 2,8-Diazo bicyclo Nonane 2-57
2.21 Process Flow diagram of 2,3,4,5-Bis-O- (1- methylethylidene)-b-D-
fructopyranose 2-61
2.22 Process Flow diagram of 2- Acetyl Ethoxy acetyl methoxy ether 2-63
2.23 Process Flow diagram of N,N-Carbonyl di imidazole 2-64
2.24 Process Flow diagram of (2S,3S,5S)-2-Amino-3-Hydroxy-5-Tert- 2-67
Butylcarbonyl Amino 1,6-diohenyl
2.25 Process Flow diagram of Trans-4-(4-chlorophenyl)-cyclohexane carboxylic 2-71
acid
2.26 Process Flow diagram of Guanine 2-73
2.27 Process Flow diagram of Poly allyl amine HCl 2-74
2.28 Process Flow diagram of T ert-butyl 2-((4R,6S)-6-((E)-2-(4-(4-flurophenyl)-6- 2-76
isopropyl-2-(N- methylmethane sulfonamido) Pyrimidin - 5-yl)vinyl)-2,2-
2.29 Process Flow diagram of 5-Cyano phthalide 2-81
2.30 Process Flow diagram of 1,1-Cyclohexanediacetic acid 2-83
2.31 Process Flow diagram of Carbamyl Methyl-5-Methyl hexanoic Acid 2-85
2.32 Process Flow diagram of 2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine 2-88
2.33 Process Flow diagram of N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2- 2-92
pyrimidine amine
2.34 Process Flow diagram of 4-[(4-Methylpiperazin-1-yl)methyl]benzoic acid 2-94
dihydrochloride
2.35 Process Flow diagram of 2, 3-Epoxy-2-methyl-N-[4-cyano-3- 2-97
(trifluoromethyl) phenyl] propanamide
2.36 Schematic Diagram of Effluent Treatment System 2-111
2.37 Schematic Diagram of Scrubbing System 2-120
2.38 Schematic Diagram of Solvent Recovery system 2-129
3.1 Hazelo Lab Pvt. Ltd- Site Photographs 3-2
3.2 Base map of the study area 3-6
3.3 Land use and land cover map of the study area 3-7
3.4 Soil Sampling Locations 3-8
3.5 Drainage Pattern of the Study area 3-14
3.6 Digital Elevation Model map the study area 3-15
3.7 Water Sampling Locations 3-16
3.8 Wind Rose Diagram at Plant Site 3-24
3.9 Ambient Air Quality Monitoring Locations 3-28
3.10 Noise Sampling Locations 3-32
4.1 Impacts Network For Air Environment 4-4
4.2 Impacts Network For Noise Environment 4-5
4.3 Identification of Likely Impacts For Waste Water 4-6
4.4 Impacts Network For Land Environment 4-7
4.5 Impacts Network For Soil Micro Flora Fauna 4-8
4.6 Impact Network For Socio-Economic And Cultural Environment 4-9
4.7 Isopleths Showing 24 Hourly GLC’s of SPM 4-20
4.8 Isopleths Showing 24 Hourly GLC’s of PM10 4-21
4.9 Isopleths Showing 24 Hourly GLC’s of PM2.5 4-22
4.10 Isopleths Showing 24 Hourly GLC’s of SO2 4-23
4.11 Isopleths Showing 24 Hourly GLC’s of NOX 4-24
6.1 Plant Layout of Hazelo Lab Pvt. Ltd. 6-13
6.2 Steps in Consequence Calculations 6-30
6.3 Heat Radiation Damage -30K1 Dichloro Methane Tank 6-34
6.4 Heat Radiation Damage -30K1 Toluene Tank 6-35
6.5 Heat Radiation Damage - 30Kl n-Hexane Tank 6-36
6.6 Toxic Dispersion of Ammonia Cylinder 6-39
6.7 Toxic Dispersion of 1Ton HCl Cylinder 6-39

Hazelo Lab Pvt. Ltd. Executive Summary
EXECUTIVE SUMMARY
Introduction
Pharmaceutical Chemicals are used for the benefit of human and animal health. The scale
of manufacturing of active pharma ingredients is less compared to other synthetic
organic chemicals, which are used for the manufacture of consumer products, dyes etc.
India is a major producer of active pharma ingredients contributing to wellbeing of both
human and animal population of the world.
M/s. Hazelo Lab Pvt. Ltd (Formerly known as Venlar Labs (P) Ltd.) obtained consent for
operation vide letter no. TSPCB/RCP/NLG/16644/HO/2015-986 dt. 14.08.2015 for
manufacturing bulk Drug Intermediates at Sy.Nos. 240, 242, 243, 247, 248 and 249,
Dothigudem Village, Pochampally Mandal, Yadadri Bhuvanagiri district, Telangana. It is
proposed to expand the manufacturing capacity to 14.2 TPD by acquiring additional
land area of 29.16 acres with a capital cost of Rs. 45 Crores. Total land area after
expansion is 33.485 acres and the expansion mainly involves construction and
commissioning of additional production blocks, utilities and Zero Liquid Discharge
facility. Prior environmental clearance has to be obtained from Ministry of Environment,
Forest and climate change, vide SO 1533, dated September 14, 2006, for synthetic organic
chemicals manufacturing activity. The terms of reference for the environmental impact
assessment studies was obtained from MoEF&CC vide letter no. F.No. J-11011/19/2016-
IA II (I) dated 31.03.2016 as part of environmental clearance process.
Location of the Project:

The project site is located at Survey Number 240, 242, 243, 247, 248 and 249, Dothigudem
Village, Pochampally Mandal, Yadadri Bhuvanangiri District, Telangana. The site is
located at the intersection of 170 17’ 17” (N) latitude and 780 50’ 46” (E) longitude. The site
elevation above mean sea level (MSL) is 407 m. The site is surrounded by open land in
north, west and south directions and SVR Laboratries Pvt. Ltd., in east direction. The
nearest habitation form the site is Antammagudem located at a distance of 0.65 km in
east direction. The main approach road is Dothigudem – NH9 connecting road in west
direction. National Highway-9 is at a Distance of 2.8 Km in Southwest Direction to the
site. The nearest Town is Choutuppal at a distance of 5.6 km in southeast direction and
E-1 Team Labs and consultants

nearest airport is Shamshabad located at a distance of 44 km in southwest direction.

Chinna Musi River is passing from NW to NE at a Distance of 5.8 Km in NW direction to
the site. There are seven reserve forests in the study area; Lakkaram RF at a distance of
1.2 km in south direction, Chauttuppal RF at a distance of 4.8 km in northwest direction,
Malkapuram RF at a distance of 2.2 km in west direction, Hafeezpura RF at a distance of
7 km in southwest direction, Ailaupur RF at a distance of 6.7 km in southwest direction,
Meharnagar RF at a distance of 5.3 km in northwest direction and Jalalpur RF at a
distance of 6.7 km in northwest direction are in the impact area. There is no National
Park, Wildlife sanctuary, ecologically sensitive area, critically polluted area and interstate
boundary within the impact area of 10 km surrounding the site.
Product Profile
The manufacturing capacity of proposed products after expansion is presented in the
following table
Manufacturing Capacity – After Expansion
S.No Name of Product CAS No. Capacity
(TPD)
1 Amlodipine Besylate 88150-42-9 0.33
2 Bupropion HCl 34841-39-9 0.83
3 Clopidogrel Hydrogen Sulfate 113665-84-2 0.33
4 Desvelofloxin Succinate 386750-22-7 0.17
5 Divolproex Sodium 76584-70-8 0.57
6 Dulaxetine HCl 136434-34-9 0.17
7 Esomeprazole Mg Dihydrate 217087-09-7 0.33
8 Glimepiride 93479-97-1 0.17
9 Mesalamine 89-57-6 0.17
10 Metaprolol Succinate 37350-58-6 0.50
11 Pantoprazole Sodium Sesquihydrate 138786-67-1 0.50
12 Pragabalin 148553-50-8 0.50
13 Rosuvastatin Calcium 287714-41-4 0.10
14 Sertraline HCl 79559-97-0 0.33
15 Tramadal 27203-92-5 0.67
16 Valcyclovir Hydrochloride Monohydrate 124832-27-5 0.33
17 4-[4-Chloro-1-oxobutyl]-2,2- dimethyl phenyl acetic acid 154477-54-0 0.10
methyl ester
18 N2-(1-(S)-ethoxy carbonyl-3-phenyl propyl-N6-trifluoro 116169-90-5 0.17
acetyl-L-lysine
19 2-[2-[3(S)-[3-[2-(7-Chloro-2-Quinolinyl)-ethenyl]phenyl]-3- 142569-70-8 0.10
hydroxypropyl]phenyl-2-propanol
20 2,8-Diazo bicyclo Nonane 151213-42-2 0.17
21 2,3,4,5-Bis-O- (1- methylethylidene)-b-D-fructopyranose 20880-92-6 0.83
22 2- Acetyl Ethoxy acetyl methoxy ether 1.13
23 N,N-Carbonyl di imidazole 530-62-1 1.67

24 (2S,3S,5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl Amino 183388-64-9 0.10

1,6-diohenyl
25 Trans-4-(4-chlorophenyl)-cyclohexane carboxylic acid 49708-81-8 0.10
26 Guanine 73-40-5 1.67
27 Poly allyl amine HCl 71550-12-4 0.50
28 Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4-flurophenyl)-6-isopropyl-2- 0.17
(N- methylmethane sulfonamido) Pyrimidin - 5-yl)vinyl)-2,2-
29 5-Cyano phthalide 82104-74-3 0.67
30 1,1-Cyclohexanediacetic acid 07-11-4335 1.67
31 Carbamyl Methyl-5-Methyl hexanoic Acid 181289-15-6 0.50
32 2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine 161599-46-8 0.13
33 N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine 0.33
amine
34 4-[(4-Methylpiperazin-1-yl)methyl]benzoic acid 0.33
dihydrochloride
35 2, 3-Epoxy-2-methyl-N-[4-cyano-3-(trifluoromethyl) phenyl] 0.17
propanamide
Worst Case : 20 products on Campaign basis 14.20
List of By-Products – After Expansion

S.No Name of Product Stage Name of By-Product Quantity
Kg/day TPM
1 Clopidogrel hydrogen sulfate I p-toluene sulfonic acid 180.8 5.4
2 1,1-Carbonyl diimidazole I Trichloromethanol 2782.5 83.5
Manufacturing Process
Chemical synthesis produces majority of API’s currently in the market. Chemical
synthesis consists of four steps - reaction, separation, purification, and drying. Large
volumes of solvents are used during chemical syntheses, extractions, and solvent
interchanges. The manufacturing process of the above mentioned molecules involve
various types of reactions like acetylyzation, protection, deprotection, hydrolysis etc.
The manufacturing process of all the compounds, reactions involved, material balance
are presented in chapter 2 of EIA report.
Utilities
The proposed expansion requires additional steam for both process and effluent
treatment system. It is proposed to establish coal fired boilers of capacity of 2 x 10 TPH in
addition to existing 2 TPH coal fired boiler. The DG sets required for emergency power
during load shut down is estimated at 2250 KVA and accordingly 2 x 1000 Kva DG sets

are proposed for expansion in addition to existing 1 x 250 Kva. The list of utilities is
presented in the following Table.
List of Utilities
S.No Utility Permitted Proposed After Expansion
1 Coal Fired Boilers (TPH) 1x2 2 x 10 2 x 10
1x2
2 Thermic Fluid Heater (K.Cal) 1 Lac --- 1 Lac
3 DG Sets (kVA)* 1 x 250 2 x 1000 2 x 1000
1 x 250
*DG sets will be used during load shut down by TSPDCL.
Water Requirement
Water is required for process, scrubbers, washing, cooling tower makeup, steam
generation and domestic purposes. The total water requirement after expansion is 475.7
KLD out of which 300.73 KLD fresh water and 175 KLD of recycled water. The required
water shall be drawn from ground water in addition to reuse of treated wastewater. The
water balance for daily consumption is presented in the following table;
Water Balance
Purpose INPUT (KLD) OUTPUT (KLD)
Fresh Water Recycled Water Loss Effluent
Process 93.73 105.21*
Washings 10 10
Scrubber 10 10
Boiler 95 85 10
Cooling Tower 60 165 199 26
RO/DM Rejects 24 24
Domestic 10 1.5 8.5
Water for gardening 8 8
Gross Total 300.73 175 293.5 193.71
Total 475.7 487.21
* Process effluents contain soluble raw materials, byproducts, solvents etc.
Baseline Environmental Data

The baseline data was collected in the study area during December 2016 - February 2017
The baseline data includes collection of Samples of ground water, surface water and soil,
monitoring of ambient air quality, noise levels, ecological status and meteorological
parameters. The analytical results show that the values are within the prescribed limits
for air quality. The ground water quality is observed to be above the limits for potable
purpose when compared to the prescribed standards of IS: 10500 – 2012 at few locations.

Identification and Quantification of Impacts

The impact assessment report has identified various sources of pollution and quantified
the pollution loads due to proposed unit. It has also identified the technologies to be
adopted for the mitigation and control of the same. The sources of pollution are air
emissions from utilities and process; liquid effluents from process, utilities and domestic
usage; solid wastes from process, treatment systems and utilities; and noise pollution
from utilities, and process equipment.
Impacts on Air quality: The impacts on air quality shall be due to the emissions from,
Coal Fired Boilers and standby DG sets. The incremental concentrations are quantified
using ISC-AERMOD model based on ISCST3 Algorithm. The results indicate marginal
increase in ambient air quality concentration. The predicted values for SPM, PM10, PM2.5,
SO2 and NOx are 3.5, 1.43, 0.67, 5.02 and 7.48 μg/m3 respectively at a distance of 0.5 km
in northwest direction, and the cumulative values of baseline air quality combined with
predicted values are found to be within the prescribed limits of National Ambient Air
Quality Standards. The mitigative and control measures of air pollution shall ensure that
the impact on air quality is local – within the site area and its surroundings. The fugitive
and diffuse emissions were quantified and a box model was used to predict air borne
concentrations, and the results indicate the work room concentrations less than threshold
limit values (TLV) for various solvents.
Impacts on Water: Water is essentially used for process and utilities and domestic
purposes. The total fresh water required of quantity 300.73 KLD after expansion will be
drawn from ground water sources in addition to recycled water of 175 KLD. No impact
on water quality is expected due to discharge of effluents as zero liquid discharge is
envisaged, which ensures reuse of treated effluents for cooling tower makeup and
scrubbers. There is no usage of treated water for on land irrigation. Impacts on Noise
quality: The noise levels may increase due to motors, compressors, DG set and other
activities. The major source of noise generation is DG set which emit noise level of
maximum 90 dB (A) at a reference distance of 1m from the source. The predicted
cumulative noise levels (as calculated by the logarithmic model without noise
attenuation) ranged between 55 and 75 dB(A) at distances of 8 to 15m. Impacts on Soil:
The solid wastes generated from process, utilities and effluent treatment plant may have

significant negative impacts if disposed indiscriminately. The total solid waste will be
stored separately in Hazardous storage area. Solid waste will be sent to cements plants
for co-incineration based on calorific value or sent to TSDF. The operational phase
impacts shall be neutral due to effective implementation of mitigative measures in
handling, storing and transferring of solid wastes, effluents and chemicals, and
development of green belt.
Impacts on Ecology: There are no endangered species of flora and fauna in the impact
area. The impact on biological environment is neutral with the effect confined mainly to
the site area.
Impacts on Socio Economy: There is a potential for direct/indirect employment of about

75 people during construction phase and 200 during operation phase. The impact area
with low industrial density will have positive benefits due to the project. The project
shall have positive impact on socioeconomic environment due to provision of
employment both direct and indirect and proposed CSR activities.
Environment Management Plan

The management plan is drawn in consultation with project proponents and technical
consultants after evaluating various mitigaton and control measures to address the
impacts identified, predicted and monitored. The impacts during construction stage are
temporary and less significant, the management plan for impacts identified during
operation stage is described as follows;
Liquid Effluents
The effluent generated from the proposed expansion is mainly from process, washings,
scrubbers, cooling towers & boiler blow downs, RO/DM rejects from pre-treatment of
water and domestic effluent. The effluents from process, washings, scrubber and
RO/DM rejects are considered as HTDS stream, while utility blow downs and domestic
wastewater are considered LTDS stream. It is proposed to treat HTDS effluents from
process and washing in stripper followed by MEE and ATFD, and MEE and ATFD in
the case of effluents from RO/DM backwash and scrubber. All LTDS effluent along with
condensate from MEE & ATFD shall be treated in Biological treatment followed by RO
system. RO Rejects sent to MEE and permeate is used for cooling towers as make up and

scrubbers. Total Effluent generated and mode of treatment before and after expansion is
presented as follows:
Total Effluent Generated and Mode of Treatment
Description Quantity (KLD) Mode of Treatment
Permitted After
Expansion
HTDS Effluents
Process 4.52 105.21 Sent to Stripper followed by MEE and ATFD.
Washings 1 10 Stripper Condensate sent to Cement Plants for
Co-Incineration. MEE and ATFD Condensate
sent to Biological treatment plant followed by
RO. RO rejects are sent to MEE and permeate is
reused in cooling towers make-up and
scrubbers.
Scrubber Effluent 10 Sent to MEE followed by ATFD, Biological
RO/DM Plant 24 treatment plant and RO.
Rejects
Total I 5.52 149.21
LTDS Effluents
Boiler Blow downs 1 10 Sent to Biological Treatment System followed by
Cooling Tower 0.5 26 RO. RO permeate reused for cooling tower
Blow downs makeup and scrubbers. RO rejects sent to MEE.
Domestic 1 8.5
Total II 2.5 44.5
Grand Total (I+II) 8.02 193.71
Effluent Treatment System

The Effluent management system is developed to ensure `Zero Liquid Discharge’.
Segregation of effluents is an integral part that facilitates effective treatment of various
effluent streams. The effluents are segregated into two streams; High COD/ TDS and
Low COD/ TDS streams.
The High TDS/ COD Effluents

The treatment system for treating High TDS/ COD effluents consists of Equalization,
Neutralization, Settling tank, Stripper, Multiple Effect Evaporator (MEE) followed by
Agitated Thin Film Dryer (ATFD). The organic distillate from the stripper is sent to
cement plants for co-incineration and aqueous bottom from stripper is sent to MEE
followed by ATFD for evaporation. The condensate from the MEE and ATFD are sent to
ETP (Biological). Salts from ATFD are disposed to TSDF.

The Low TDS/ COD Effluents:

These effluents along with the condensate from MEE and ATFD are treated in primary
treatment consisting of equalization, neutralization, and primary sedimentation followed
by secondary biological treatment consisting of aeration tank and clarifier.
The treated effluents after biological treatment are subjected to tertiary treatment in a
reverse osmosis (RO) system. Permeate from RO is reused for cooling tower and boiler
make-up and rejects are sent to MEE followed by ATFD. Sludge from various units of
Biological treatment are thickened in sludge handling system and sent to TSDF.
Air Pollution
The sources of air pollution are from proposed 2 x 10 TPH coal fired boiler, existing 1 x 2
TPH and existing 1 Lakh K.Cal thermic fluid heater. Backup DG sets of 2 x 1000 KVA are
proposed in addition to existing DG sets of 1 x 250 KVA capacity to cater energy
requirement during load shut downs. Bag filter will be provided as air pollution control
equipment for 2 x 10 TPH coal fired boilers. DG sets shall be provided with effective
stack height based on the CPCB formula.
Process emissions contain Ammonia, Carbon dioxide, carbon monoxide, Hydrogen,

Hydrogen Bromide, Bromine, Hydrogen Chloride, and Sulfur dioxide. Ammonia,
Hydrogen chloride, Hydrogen Bromide, Bromine and Sulphur dioxide are sent to
scrubber in series. Ammonium Chloride from ammonia scrubbing, Sodium chloride
from HCl scrubbing, Sodium bromide from HBr and Bromine Scrubbing and Sodium
Bisulfite from Sulphur dioxide Scrubbing are sent to ETP. The other gases Carbon
dioxide and carbon monoxide are let out into atmosphere following a standard operating
procedure, while Hydrogen gas is let out into atmosphere through a water column.
Emissions are also released from various operations of manufacturing like centrifuge,
drying, distillation, extraction etc. These emissions mainly contain volatile contents of
the material used for processing. It is proposed to provide vent condensers in series to
reactors, distillation columns, driers and centrifuge etc. to mitigate VOC emissions
release. Other vents are connected to common headers and scrubbers.

Solvent Use and Recycle

Solvents are used for extraction of products and as reaction medium. Used solvents are
recovered by distillation, for reuse. Residues from distillation columns and mixed
solvents shall be sent to TSDF for incineration or cement plants for co-incineration. If any
of the distilled spent solvents are not reused due to statutory reasons the same shall be
sold to end users.
Solid Waste
Solid wastes are generated from process, solvent distillation, effluent treatment system,
DG sets and boilers. Stripper distillate, process residue and solvent residue are sent to
cement plants for co-incineration based on acceptability as the same contain significant
calorific value and are predominantly organic in nature. If these wastes are not suitable
for co-incineration, the same are sent to TSDF facility. The evaporation salts from ATFD ,
and sludge from ETP are sent to TSDF for landfill. Waste oil and used batteries from the
DG sets are sent to authorized recyclers. Other solid wastes expected from the unit are
containers, empty drums which are returned to the product seller or sold to authorized
buyers after detoxification. Coal ash from boiler is sold to brick manufacturers.
Noise Pollution
Noise is anticipated from motors, compressors, centrifuges and DG sets. DG set shall be
provided with acoustic enclosure. Motors and compressors shall be mounted properly to
ensure reduction of noise and vibration. Employees working in noise generating areas
shall be provided with appropriate personnel protective equipment.
Occupational Safety and Health
Direct exposure to chemicals or its raw materials may affect health of employees. Direct
exposure to hazardous materials is eliminated by providing closed handling facilities.
Personal Protective Equipment (PPE) i.e., hand gloves, safety goggles, safety shoes,
safety helmets, respiratory masks etc. are provided to all the employees working in the
plant. Company has a policy of providing PPEs to all personnel including contract
workers. Periodic medical checkup in addition to checkup during recruitment is adopted
to monitor health status of employees.

Prevention, maintenance and operation of Environment Control Systems
The pollution control equipment, and the effluent treatment system is monitored
periodically to estimate their efficiency and performance potential as part of adoptive
management. Proactive maintenance and monitoring program for all equipment and
machinery is adopted to identify the problems/under performance of the equipment.
Necessary measures will be adopted to rectify the identified problems/defects. The
management agrees that the results of monitoring will be reviewed periodically to adopt
new measures if necessary, for efficient pollution control.
Transport systems
All the raw materials and finished products are transported by road. Dedicated parking
facility is provided for transport vehicles. There will be 10-12 truck trip per day to the
factory for transporting raw materials and products. Traffic signs will be placed in the
battery limit. The drivers of vehicles will be provided with TREM cards of chemicals and
materials to be transported, and will be explained the measure to be adopted during
various emergencies
Reduce, Recycle and Reuse

A number of measures are proposed to achieve high yields and reduce generation of
wastes. It shall be endeavor of the R&D team to improve yields through constant
research and development activities. The solvents shall be recycled for reuse in the
process after distillation. Mother liquors from the first crop shall be reused for process.
The steam condensate shall be reused for boiler feed. Treated effluent shall be reused for
cooling tower makeup. It is also proposed to explore recovery of various salts from MEE
salts, and from process effluents to reduce effluent loads, and quantity of solid waste.
Green Belt Development

Green belt is recommended as one of the major components of EMP. The management
proposes to develop green belt in a total area of 11.5 acres, to enhance environmental
quality through mitigation of fugitive emissions, attenuation of noise levels, balancing
eco-environment, prevention of soil erosion, and creation of aesthetic environment.

Post Project Monitoring

Environmental monitoring for water, air, noise and solid waste quality shall be
conducted periodically either by proponent or third party. The frequency of monitoring
and the quality parameters shall be as suggested by the Ministry of Environment and
Forests and Climate Change, Government of India.
Environment Management Department

The Environment Management Cell of the project shall be headed by the Vice President
followed by Sr. GM Operation, senior manager EHS, Executive Environment and shall be
assisted Technicians and chemists of SHE cell, and horticulture staff.

Hazelo Lab Pvt. Ltd. Environmental Impact Assessment Report
1.0 INTRODUCTION
1.0 Introduction of the Project (Terms of Reference No. 2(ii) & 2(iii))
The pharmaceutical industry is an important component of health care systems
throughout the world; it is comprised of many public and private organizations that
discover, develop, manufacture and market medicines for human and animal health.
The pharmaceutical industry is based primarily upon the scientific research and
development (R&D) of medicines that prevent or treat diseases and disorders. Modern
scientific and technological advances are accelerating the discovery and development
of innovative pharmaceuticals with improved therapeutic activity and reduced side
effects. Industrial chemicals are used in researching and developing active drug
substances and manufacturing bulk substances and finished pharmaceutical products.
Chemical synthesis produces majority of drugs currently available in the market.

Chemical synthesis consists of four steps - reaction, separation, purification, and
drying. Large volume of solvents are used during chemical syntheses, extractions, and
solvent interchanges. The bulk drug manufacturing process utilizes various process
equipment and chemical methods. Sources of emissions include dryers, reactors,
distillation units, storage and transfer of materials, filtration, extraction, centrifugation,
and crystallization. Chemical synthesis consists of one or more batch reactions
followed by separation and purification steps utilizing organic and inorganic reactants,
solvents, and catalysts, and is solvent-intensive. Waste streams generated are numerous
and complex due to the raw materials used and the varied nature of operations.
Organic synthesis generates a mother liquor containing unconverted reactants, by-
products, and residual product in a solvent or aqueous base, as well as acids, bases,
metals, etc.
The scientific research and development in API manufacturing is focused on increasing

the yields and reducing the toxicity of wastes and consumption of solvents, using
alternative manufacturing methods etc. In this context the API manufacturing is
viewed as an environmentally hazardous activity. Accordingly Ministry of
Environment and Forests, GOI mandated prior environmental clearance for synthetic
organic chemicals manufacturing units vide S.O.1533 dt. 14.9.2006.
1-1 Team Labs and consultants

M/s. Hazelo Lab Pvt. Ltd (Formerly known as Venlar Labs (P) Ltd.) obtained consent
for operation vide letter no. TSPCB/RCP/NLG/16644/HO/2015-986 dt. 14.08.2015 for
manufacturing bulk Drug Intermediates at Sy.Nos. 240, 242, 243, 247, 248 and 249,
Dothigudem Village, Pochampally Mandal, Yadadri Bhuvanagiri district, Telangana. It
is proposed to expand the manufacturing capacity to 14.2 TPD by acquiring additional
land area of 29.16 acres with a capital cost of Rs. 45 Crores. Total land area after
expansion is 33.485 acres and the expansion mainly involves construction and
commissioning of additional production blocks, utilities and Zero Liquid Discharge
facility. Prior environmental clearance has to be obtained from Ministry of
Environment, Forest and climate change, vide SO 1533, dated September 14, 2006, for
synthetic organic chemicals manufacturing activity. The terms of reference for the
environmental impact assessment studies was obtained from MoEF&CC vide letter no.
F.No. J-11011/19/2016-IA II (I) dated 31.03.2016 as part of environmental clearance
process.
M/s. Hazelo Lab Pvt. Ltd., is conscious of its responsibility towards the society in
minimizing the pollution load due to the proposed expansion of synthetic organic
chemicals manufacturing and accordingly decided to carry out the Environmental
Impact Assessment to identify the negative and positive impacts and to delineate
effective measures to control the pollution and to mitigate the environmental pollution.
M/s. Hazelo Lab Pvt. Ltd., has appointed Team Labs and Consultants for the
preparation of Environmental Impact Assessment report.
Immediately after the receipt of the work order for the preparation of EIA report, the
collection of primary (field data) and secondary (data available with various state and
central government agencies) data has begun. Reconnaissance survey of the region
was carried out during of November 2016, and various sampling locations to monitor
environmental parameters have been identified. Subsequently, monitoring has
commenced for collection of data on meteorology, ambient air quality, surface and
ground water quality, soil characteristics, noise levels flora and fauna at the specified
locations during December 2016 - February 2017. The other studies such as socio-
economic profile, land use pattern etc are based on secondary data collected from

various Government agencies and validated through the primary surveys. The
Ambient air monitoring locations have been selected based on the initial Air dispersion
Modeling carried out by using the meteorological data generated at India
Meteorological Department (IMD).
Field team of M/s. Team Labs and Consultants worked in the study area during
December 2016 - February 2017 and base line data for various environmental
components i.e., air, water, soil, noise and flora and fauna and socio economic status of
people was collected in a circular area of 10 km radius by taking the industry site as the
center point, to assess the existing environmental status as per the guidelines specified
by Ministry of Environment, Forest and Climate Change (MoEF&CC), Government of
India. This report presents the results of environmental impact assessment study along
with the environmental management plan, necessary to avoid or mitigate the observed
environmental impacts of the proposed expansion of synthetic organic chemicals
manufacturing unit.
1.1 Product Profile (Terms of Reference No. 3(ii) & (iii))

The manufacturing capacity of permitted and after expansion products are presented in
Table 1.1 and Table 1.2. List of By-products after expansion is presented in Table 1.3.
Table 1.1 Manufacturing Capacity - Permitted
S.No Name of Product Capacity
Kg/Day TPA
Group A*
1 α-Amino compound 100 30
2 Pyrazole 100 30
Total 200 60
Group B*
3 Bromophthalide 100 30
4 Cyanodiol HBr 150 45
5 Cyanophtalide 100 30
Total 350 105
Note: The above products are manufactured on campaign basis, i.e. at any point of time only one group
will be manufactured.

Table 1.2 Manufacturing Capacity – After expansion

(TPD)
2 Bupropion HCl 34841-39-9 0.83
6 Dulaxetine HCl 136434-34-9 0.17
8 Glimepiride 93479-97-1 0.17
12 Pragabalin 148553-50-8 0.50
14 Sertraline HCl 79559-97-0 0.33
15 Tramadal 27203-92-5 0.67
methyl ester
acetyl-L-lysine
1,6-diohenyl
26 Guanine 73-40-5 1.67
29 5-Cyano phthalide 82104-74-3 0.67
amine
dihydrochloride
propanamide

Table 1.3 List of By-Products – After Expansion

Kg/day TPM
1.2 Technology
The technology for the product profile is indigenous based on organic chemistry. The
product profile has been finalized based on the market demand and the technology
compatibility. The synthesis involves reaction of fine chemicals in a solvent medium,
followed by separation and purification.
1.3 Plant Location & Layout

The project site is located at Survey Number 240, 242, 243, 247, 248 and 249,
Dothigudem Village, Pochampally Mandal, Yadadri Bhuvanangiri District, Telangana.
The site is located at the intersection of 170 17’ 17” (N) latitude and 780 50’ 46” (E)
longitude. The site elevation above mean sea level (MSL) is 407 m. The site is
surrounded by open land in north, west and south directions and SVR Laboratries Pvt.
Ltd., in east direction. The nearest habitation form the site is Antammagudem located
at a distance of 0.65 km in east direction. The main approach road is Dothigudem –
NH9 connecting road in west direction. National Highway-9 is at a Distance of 2.8 Km
in Southwest Direction to the site. The nearest Town is Choutuppal at a distance of 5.6
km in southeast direction and nearest airport is Shamshabad located at a distance of 44
km in southwest direction. Chinna Musi River is passing from NW to NE at a Distance
of 5.8 Km in NW direction to the site. There are seven reserve forests in the study area;
Lakkaram RF at a distance of 1.2 km in south direction, Chauttuppal RF at a distance of
4.8 km in northwest direction, Malkapuram RF at a distance of 2.2 km in west direction,
Hafeezpura RF at a distance of 7 km in southwest direction, Ailaupur RF at a distance
of 6.7 km in southwest direction, Meharnagar RF at a distance of 5.3 km in northwest
direction and Jalalpur RF at a distance of 6.7 km in northwest direction are in the
impact area. There is no National Park, Wildlife sanctuary, ecologically sensitive area,
critically polluted area and interstate boundary within the impact area of 10 km
surrounding the site. The location map and site layout is as shown in Fig 1.1 and Fig
1.2.

Fig 1.1 Location of M/s. Hazelo Lab Pvt. Ltd., (Terms of Reference No. 4(ii))

S C A L E 1 C m = 0 0 m trs
FUTUR
E
FUTUR
E
U NLOA ROAD
D IN G 7.0 M
FUTUR
E FUTUR
E
SOLVE
4 5 .3 x 6 N T YARD
0 .0
L R M -I
4 0 .0 x 2 0
.0
W AREH
O U S E -I
4 0 .0 x 2 0
.0
TEM PL
1 0.0x 10
E
FUTUR
.0 E
L R M -II
4 0.0x 2 0
.0
W AREH
O U S E -II
4 0 .0 x 2 0 STORM
.0
Q C& QA W ATER
7 0 .0 x 2 0
.0 POND
CANTE
EN &
CHANG
2 8 .0 x 2 0 E ROOM
.0 PROPO ROAD 5 5 0 .0 x 2 0 S
SED B L .0 M .0
OCK
4 0 .0 x 2 0
.0 PROPO
SED B L
4 0 .0 x 2 0 OCK
.0
PRO PO
SED P
7 0.0x 20 IL O T P L A N T
.0
ROAD 5
.0 M
FUTUR
E
FUTUR
E
FUTUR
E
PRO PO ROAD 5
SE D B L .0 M
OCK
4 0 .0 x 1 9
.0 PRO PO
SE
4 0.0x 1 9 D B L O C K
.0
P RO PO
SED
PROPO
SED B L
7 0 .0 x 1 9 OCK
PRO PO .0
D C SED TANKS
8 .0 X 1 2 .5
M 1 4 .0 X 1 2 .5 M PRO D U ZLD Sy
C T IO
4 0 .0 x 1 2N B L O C K
ROAD
5 .0 M s te m
.5 IN T ER M
E D IA T
E STO R
4 0 .0 x 1 2 AGE
.5 P RO PO
S E R V IC SED
E BLO
7 0 .0 x 1 2 C K
.5
COAL S
ROAD
5 .0 M
HED
2 0 .0 x 1 2 B O IL E
.5 2 5 .0 x 1 2 R
.5
Fig 1.2 Plant Layout of M/s. Hazelo Lab Ltd., (Terms of Reference No. 4(vi) & (viii))

1.4 Scope of EIA Studies
EIA study involves three basic components, viz. identification, prediction and
evaluation of impacts. The scope of EIA study incorporating the Terms of reference
(TOR) obtained from the MoEF is as follows:
• An intensive reconnaissance and preliminary collection of environmental

information to plan field study.
• Field studies to collect preliminary information, particularly on the quality of

the physical environment. Experienced scientists and engineers will collect the
data.
• Base line data generation and characterization of air, water, soil, noise and
vegetation in the ten kilometer radius area (impact zone) over a period of Three
months.
• A thorough study of the process including provisions for pollution control, and
environmental management that includes prediction of impacts and relevant
mathematical modeling.
• Preparation of Environmental Monitoring Program.
• Preparation of Environmental Management Plan suggesting suitable methods

for mitigating and controlling the pollution levels. Environmental Monitoring
Plan is suggested for monitoring the pollution loads at various facilities in the
premises and to ensure compliance with the statutory requirements.

Hazelo Lab Pvt. Ltd., Environmental Impact Assessment Report
2.0 PROCESS DESCRIPTION AND POLLUTION CONTROL FACILITIES
M/s. Hazelo Lab (P) Ltd (Formerly known as Venlar Labs (P) Ltd.,) obtained consent for
operation for Bulk Drug Intermediates at Sy.Nos. 240, 242, 243, 247, 248 and 249,
Dothigudem Village, Pochampally Mandal, Yadadri Bhuvanagiri district, Telangana. It is
proposed to expand the manufacturing capacity from 0.35 TPD to 14.2 TPD to meet the
increasing market demands by acquiring additional land area of 29.16 acres, total land area
after expansion is 33.485 acres. The expansion entails a capital cost of Rs. 45.0 Crores
towards additional production blocks, utilities and Zero Liquid Discharge facility.
Manufacturing Capacity permitted and after Expansion is presented in Table 2.1 and 2.2.
List of By-Products presented in Table 2.3.
Table 2.1 Manufacturing Capacity - Permitted
S.No Name of Product Capacity
Kg/Day TPA
Group A*
1 α-Amino compound 100 30
2 Pyrazole 100 30
Total 200 60
Group B*
3 Bromophthalide 100 30
4 Cyanodiol HBr 150 45
5 Cyanophtalide 100 30
Total 350 105
Note: The above products are manufactured on campaign basis, i.e. at any point of time only one group will
be manufactured.
Table 2.2 Manufacturing Capacity - after Expansion

(TPD)
2 Bupropion HCl 34841-39-9 0.83
6 Dulaxetine HCl 136434-34-9 0.17
8 Glimepiride 93479-97-1 0.17
2-1 Team Labs and Consultants

12 Pragabalin 148553-50-8 0.50

14 Sertraline HCl 79559-97-0 0.33
15 Tramadal 27203-92-5 0.67
methyl ester
acetyl-L-lysine
1,6-diohenyl
26 Guanine 73-40-5 1.67
29 5-Cyano phthalide 82104-74-3 0.67
amine
dihydrochloride
propanamide
Table 2.3 List of By-Product - after Expansion

Kg/day TPM

2.1 Process Description: (Terms of Reference No. 3(viii))

2.1.1 Process Description of Amlodipine Besylate
Reaction Schemes
Stage I
C l M e t h y le n e C h lo r id e
2H 2 O
C H 3
O O C C O O C 2
H 5 O +
M .W t:3 6 M o n o m e t h y l a m in e
O B e n z e n e s u lf o n ic a c id ( 1 5 8 )
H 3
C N N
H
O
P h t h a lim id o A m lo d ip in e
M .W t:5 3 9
C l
P h t h a lic a c id
C H O O C C O O C H
3 2 5 .B e n z e n e s u lfo n ic a c id + M .W t:1 6 6
O
H 3 C N N H 2
H
A m lo d ip in e B e s y la te
(P h a rm a )
M .W t:5 6 7
Process Description:
Stage – I: Phthalimido amlodipine is treated with benzene sulphonic acid in presence of
Mono methyl amine to give Amlodipine besylate (Pharma). Process flow diagram can be
represented in Fig 2.2. Material balance represented in Table 2.4.
P h th a lim id o A m lo d ip in e
M o n o m e th y l a m in e
B e n z e n e S u lp h o n ic a c id P h th a lic a c id
M e th y le n e c h lo r id e D e p r o t e c t io n
M e th a n o l
& W a s te W a te r
E th y l a c e ta te
W a te r S a lt f o r m a t io n
N aC l
A c tiv a te d c a r b o n
S o d iu m b is u lp h a te
A m lo d ip in e b e sy la te
(P h a rm a )
Fig 2.1 Process Flow Diagram of Amlodipine Besylate

Table 2.4 Material Balance for Amlodipine Besylate

Input Quantity Output Quantity Remarks
(Kg/day) (Kg/day)
Phthalimido Amlodipine 425 Amlodipine Besylate 333.3 Final Product
Water 28 Phthalic acid 97.6 To wastewater
Methylene Chloride 1200 Methanol Recovered 1425 Recovery & reuse
(MDC)
Mono Methyl amine 750 Methanol Loss 12 Fugitive Loss
(MMA)
Benzene sulfonic acid 125 Methanol to wastewater 9 To Wastewater
Sodium Chloride 150 Methanol to Residue 54 Solvent in Residue
Sodium Bisulphate 80 MDC Recovered 1152 Recovery & reuse
Methanol 1500 MDC Loss 8.4 Fugitive Loss
Ethyl acetate 800 MDC to Residue 39.6 Solvent in Residue
Activated Carbon 20 Ethyl acetate Recovered 736 Recovery & reuse
Celite 12 Ethyl acetate Loss 3.2 Fugitive Loss
Water 3500 Ethyl acetate to water 8.8 To Wastewater
Ethyl acetate to Residue 52 Solvent in Residue
MMA Recovered 720 Recovery & reuse
MMA Loss 5.3 Fugitive Loss
MMA to wastewater 9.8 To Wastewater
MMA to Residue 14.9 Solvent in Residue
Phthalimido Amlodipine 107.9 Organic Residue
Benzene sulfonic acid 32 To wastewater
Activated Carbon 20 To Spent carbon
Sodium Chloride 150 To Wastewater
Sodium Bisulphate 80 To Wastewater
Celite 12 Inorganic residue
water 3507 To Wastewater
Total Input 8589.6 Total Output 8589.6

2.1.2 Process Description of Bupropion Hydrochloride

Reaction Schemes
Stage I
O
CH3
Cl C H3
+ N a 2S 2O 5
H3C NH2 + HCl + B r2
H yd ro g e n B r o m in e N a 2S 2O 3
CH3
c h lo r id e
M .W t : 1 6 0 T o lu e n e
T e r t- b u ty la m in e M .W t : 3 6 .5
m - C h lo r o p r o p io p h e n o n e
M .W t : 7 3
M .W t : 1 6 8 .5
O
H CH3
Cl N
CH3
CH3 + 2H Br
CH3
.H C l M .W t : 1 6 2
B u p r o p io n H y d r o c h lo r id e ( C r u d e )
M .W t : 2 7 6
Stage II
Methanol
Bupropion Hydrochloride (Crude) Bupropion Hydrochloride (Pharma)
Acetone
Stage – I: M-Chloropropiophenone is reaced with Tert-butylamine, hydrogenchloride and

bromine in presence of sodium bisulphate in methylene chloride to yield Bupropion
Hydrochloride (Crude).
Stage – II: Bupropion Hydrochloride (Crude) is purified in presence of Methanol and

acetone to give Bupropion Hydrochloride (Pharma). The process flow diagram for
Bupropion Hydrochloride is presented in Fig 2.2. Material balance presented in Table 2.5.

Buropipon Hydrchloride Crude

m-chloropropiophenone
Bromine Hydrogen Bromide
Tert-butylamine N-methyl-2-pyrrolidone
Hydrogenchloride Methylene chloride
Sodiummeta bisulphate Stage - I Toluene

Sodiumthiosulfate Acetone
N-methyl-2-pyrrolidone
Waste Water
Methylene chloride
Toluene
Acetone
Water
Buropipon Hydrchloride Crude
Methanol Methanol
Stage - II
Acetone
Acetone
Activated Carbon
Bupropion Hydrochloride
(Pharma)
Fig 2.2 Process Flow Diagram of Bupropion Hydrochloride

Table 2.5 Material Balance for Bupropion Hydrochloride

Stage I
(Kg/day) (Kg/day)
m-Chloropiophenone 617.1 Stage I Product 902.6 To Stage II
Tert-butylamine 267.3 Hydrogen bromide 529.8 To Scrubber
Hydrogen Cloride 133.7 NMP Recovered 482.5 Recoverd & Reused
Bromine 523 NMP Loss 2.5 Fugitive Loss
Sodiummeta bisulfite 200 NMP to Wastewater 5 To Wastewater
Sodium thiosulphate 160 NMP to Residue 100 Solvent in Residue
N-methyl Pyrrolidone 500 MDC Recovered 2910 Recoverd & Reused
Methylene chloride 3000 MDC Loss 12 Fugitive Loss
(MDC)
Toluene 3200 MDC to Residue 78 Solvent in Residue
Acetone 750 Toluene Recovered 3104 Recoverd & Reused
Water 3200 Toluene Loss 12.8 Fugitive Loss
Toluene to Residue 83.2 Solvent in Residue
Acetone Recovered 723.8 Recoverd & Reused
Acetone Loss 3.8 Fugitive Loss
Acetone to Wastewater 7.5 To Wastewater
Acetone to Residue 15 Solvent in Residue
m-Chloropiophenone 66 Organic Residue
Tert-butylamine 28.6 To waste water
Hydrogen Chloride 14.3 To Scrubber
Sodiummeta bisulfite 200 To Wastewater
Sodium thiosulphate 160 To Wastewater
Water 3200 To Wastewater
Stage II
(Kg/day) (Kg/day)
Stage I Product 902.6 Bupropion HCl 833.3 Final Product
Methanol 2800 Methanol Recovered 2702 Recovered & Reused
Acetone 3000 Methanol Loss 14 Fugitive Loss
Activated Carbon 30 Methanol to Residue 84 Solvent in Residue
Acetone Recovered 2910 Recovered & Reused
Acetone Loss 12 Fugitive Loss
Acetone to Wastewater 15 To Wastewater
Stage I Product 69.3 Organic residue

2.1.3. Process Description of Clopidogrel Hydrogen Sulfate

Reaction Schemes:
S T A G E -I
L iq . A m m o n ia
O O O
CH3 O D ip o t a s s iu m h y d r o g e n
S p h o s p h a te
O
H2N
. T a r t a r ic a c id s a lt + S CH3
Cl HCl
( 2 - T h ie n y l) e th y lp a r a - t o u le n e W a te r
M e t h y l( + ) - a lp h a - a m in o ( 2 - c h lo r o p h e n y l) s u lp h o n a t e
a c e t a t e t a r t a r ic a c id s a lt
M .W t: 2 8 2
M .W t: 3 4 9 .5
C O O CH3 S O3H
OH O
HN HO
+ OH +
S Cl
O OH
CH3
M e t h y l ( + ) - a lp h a - ( 2 - th ie n y le th y la m in o )
( 2 - c h lo r o p h e n y l) a c e ta t e T a r ta r ic a c id p - T o lu e n e s u lf o n ic a c id
M .W t: 1 5 0 M .W t: 1 7 2
M .W t: 3 0 9 .5
S T A G E -II
C O O CH3 A c e to n e
L ( - ) c a m p h o r s u lp h o n ic a c id
HN + H 2S O
+ HCHO 4
S Cl
M .W t: 3 0 M .W t: 9 8 S o d iu m b ic a r b o n a te
M e t h y l ( + ) - a lp h a - ( 2 - t h ie n y le t h y l A c t iv a t e d c a r b o n
a m in o ) ( 2 - c h lo r o p h e n y l) a c e t a t e
W a te r
M .W t: 3 0 9 .5
C O O C H3
N -
.H S O 4 + H 2O
S Cl
M .W t:1 8
C lo p id o g r e l h y d r o g e n s u lfa te (P h a r m a )
M .W t: 4 1 9 .5
Stage-I: Methyl(+)-alpha-amino(2-chlorophenyl)acetate tartaric acid salt is condensed with
(2-thienyl)ethylpara-toulene sulphonate in the presence of Liq. Ammonia in ethyl acetate
and water to give methyl(+)-alpha-(2-thienylethylamino)(2-chlorophenyl)acetate.
Stage-II: methyl(+)-alpha-(2-thienylethylamino)(2-chlorophenyl)acetate is condensed with

formaldehyde and on treatment with sulfuric acid in the presence of acetone and water to
yield Clopidogrel hydrogen sulfate (Pharma). Process flow diagram can be presented in Fig
2.3.Material balance can be presented in Table 2.6.

Methyl(+)-alpha-amino(2-chlorophenyl) Methy(+)-alpha-(2-thienylethylamino)
acetate tartaric acid (2-chlorophenyl)acetate
(2-Thienyl)ethylpara-toulene
Liq.Ammonia
sulphonate
Liq.Ammonia Methylene dichloride
Stage-I
Methylene dichloride Dipotassim hydrogen phosphate
Condenisation Ethyl acetate
Dipotassim hydrogen phosphate
Hydrochloric acid
Ethyl acetate
Tartaric acid
Hydrochloric acid P-Toulene sulphonic acid
Water Waste water
Methy(+)-alpha-(2-thienylethylamino) Acetone
(2-chlorophenyl)acetate
Formaldehyde Methylene dichloride
Stage-II
Sulfuric acid L(-)-camphor sulphonic acid
Acetone Cyclisation Ethyl acetate
Methylene dichloride
Sodium bicarbonate
L(-)-camphor sulphonic acid Saltification
Ethyl acetate Methyl isobutyl ketone
Sodium bicarbonate
Activated carbon
Methyl isobutyl ketone
Activated carbon Waste water
Water
Clopidogrel hydrogen sulfate

(Pharma)
Fig 2.3 Process Flow Diagram of Clopidogrel Hydrogen Sulfate

Table 2.6 Material Balance for Clopidogrel Hydrogen Sulfate

Stage I
(Kg/day) (Kg/day)
Methyl(+)-alpha- 421.4 Stage I Product 325.4 To Stage II
amino(2-
chlorophenyl)acetate
tartaric acid salt
(2-Thienyl)ethyl para- 340 Tartaric acid 157.7 To Wastewater
toulene sulphonate
Liq. Ammonia (20%) 60 p-toluene sulfonic acid 180.8 By-Product
Methylene Dichloride 800 MDC Recovered 772 Recovered & Reused
(MDC)
Dipotassium hydrogen 54 MDC Loss 4 Fugitive Loss
phosphate
Ethyl acetate 1000 MDC to Residue 24 Solvent in Residue
Hydrochloric acid 26 Ethyl acetate Recovered 970 Recovered & Reused
Water 1800 Ethyl acetate Loss 4 Fugitive Loss
Ethyl acetate to water 5 To Wastewater
Ethyl acetate to Residue 21 Solvent in Residue
Methyl(+)-alpha- 53.9 Organic Residue
amino(2-
chlorophenyl)acetate
tartaric acid salt
(2-Thienyl)ethyl para- 43.5 Organic Residue
toulene sulphonate
Dipotassium hydrogen 54 Inorganic residue
phosphate
Ammonium Chloride 37.8 To Wastewater
Stage II
(Kg/day) (Kg/day)
Stage I Product 325.4 Clopidogrel Hydrogen 333.3 Final Product
Sulfate
Formaldehyde 31.5 Ethyl acetate Recovered 1447.5 Recovered & Reused
Sulfuric acid 103 Ethyl acetate Loss 7.5 Fugitive Loss
Acetone 1200 Ethyl acetate to water 15 To Wastewater
L-(-)-Camphor 15 Ethyl acetate to Residue 30 Solvent in Residue
sulphonic acid
Methylene dichloride 2000 MIBK Recovered 1164 Recovered & Reused
(MDC)
Ethyl acetate 1500 MIBK Loss 4.8 Fugitive Loss
Sodium bicarbonate 60 MIBK to Wastewater 6 To Wastewater
Methyl isobutyl ketone 1200 MIBK to Residue 25.2 Solvent in Residue

(MIBK)
Activated Carbon 40 MDC Recovered 1930 Recovered & Reused
Water 1500 MDC Loss 10 Fugitive Loss
Sodium hydroxide 20.5 MDC to Residue 60 Solvent in Residue
Acetone Recovered 1158 Recovered & Reused
Acetone to Wastewater 18 To Wastewater
Stage I Product 79.5 Organic Residue
L-(-)-Camphor 15 Organic Residue
sulphonic acid
Formaldehyde 7.7 Organic Residue
Sodium sulfate 36.5 To Wastewater
Sodium bicarbonate 60 To Wastewater
Water 1523.5 To Wastewater
2.1.4 Process Description of Desvelofloxin

Reaction Schemes
Stage I
Hydrogen
Methanol
Pd/C
Stage II

Stage–I: 1-[2-Amino- 1-(4-benzyloxyphenyl) ethyl] cyclohexanol reacted with formic acid
and formaldehyde in presence of water gives 1-[2-(Dimethylamino)-1-(4-benzyloxyphenyl)
ethyl] cyclohexanol this undergoes to reacted with pd/c and Hydrogen gas pressure in
presence of methanol to gives 1-[2-Dimethylamino)-1-(4-hydroxyphenyl) ethyl]
cyclohexanol.
Stage–II: 1-[2-(Dimethylamino)-1-(4-hydroxyphenyl) ethyl] cyclohexanol reacted with

succinic acid Inpresence of isopropyl alcohol to gives Des-Venlafaxine succinate.Process
flow diagram can be represented in Fig 2.4.Material balance represented in Table 2.7.
Fig 2.4 Process Flow Diagram of Desvelofloxin

Table 2.7 Material Balance for Desvelofloxin Succinate

Stage I
(Kg/day) (Kg/day)
1-[2-Amino-1-(4- 188.5 Stage I Product 125.1 To Stage II
benzyloxyphenyl)
ethyl] cyclohexanol
Formic acid 53.3 Toluene 43.8 To Wastewater
Formaldehyde (40%) 86.9 Carbon dioxide 41.8 Let out into
Atmosphere
10% Pd/C 15 Ethyl acetate Recovered 1447.5 Recoverd & Reused
Hydrogen gas 1.2 Ethyl acetate Loss 7.5 Fugitive Loss
Water 3000 Ethyl acetate water 15 To Wastewater
Ethyl acetate 1500 Ethyl acetate to Residue 30 Solvent in Residue
n-hexane 1000 n-hexane Recovered 970 Recoverd & Reused
Methanol 1200 n-hexane Loss 4 Fugitive Loss
Isopropyl alcohol (IPA) 300 n-hexane to Residue 26 Solvent in Residue
Methanol Recovered 1164 Recoverd & Reused
Methanol Loss 4.8 Fugitive Loss
Methanol to waste water 14.4 To Wastewater
Methanol to Residue 16.8 Solvent in Residue
IPA Recovered 292.5 Recoverd & Reused
IPA Loss 1.2 Fugitive Loss
IPA to waste water 3.6 To Wastewater
IPA to Residue 2.7 Solvent in Residue
Organics
Organic Impurities 33.9 Organic Residue
Formic acid 9.6 To waste water
Formaldehyde 6.3 Organic Residue
10% Pd/C 15 To spent Catalyst
Hydrogen gas 0.2 Let out Into
atmosphere through
water column
Stage II
(Kg/day) (Kg/day)
Stage I Product 125.1 Des-venlafaxine Succinate 166.7 Final Product
Succinic acid 51.6 IPA Recovered 482.5 Recovered & Reused
Isopropyl alcohol (IPA) 500 IPA Loss 2.5 Fugitive Loss
IPA to Wastewater 5 To Wastewater
IPA to Residue 10 Solvent in Residue
Stage I Product 10 Organic Residue

2.1.5 Process Description of Divolproex Sodium

Reaction Schemes
Stage I
Stage II
Stage –I: 2, 2-Dipropylmalonic acid is heat to 170 to 175 0C to form 2- Propylpentanoic acid
(Stage II Compound)
Stage –II: 2- Propylpentanoic acid reats with Sodium hydroxide inpresence of Methanol to
form Divalproex Sodium.Process flow diagram can be presented in Fig 2.5.Material balance
can be presented in Table 2.8.
Stage I
Stage II

Fig 2.5 Process Flow Diagram of Divolproex Sodium
Table 2.8 Material Balance for Divolproex Sodium

Stage I
(Kg/day) (Kg/day)
2,2-Dipropylmalonic 778.7 Stage I Product 578.6 To Stage-II
acid
Carbon dioxide 176.8 Let out into atmosphere
Organics
2,2-Dipropylmalonic 23.4 Organic residue
acid
Stage II
(Kg/day) (Kg/day)
Stage I Product 578.6 Divolproex Sodium 566.7 Final Product
Sodium hydroxide 73.9 Water 32.9 To wastewater
Methanol 2000 Solvents
Activated carbon 30 Methanol
Hydrochloric acid 1 Methanol Recovered 1940 Recovery & reuse
Methanol Loss 5 Fugitive Loss
Methanol to Residue 55 Solvent in Residue
Organics
2-Propylpentanoicacid 52.07 Organic residue
Activated carbon 30 To Spent carbon
Inorganics
Sodium chloride 1.2 To Waste water
Sodium hydroxide 0.8 To Neutralization
Water 0.36 To Waste water

2.1.6 Process Description of Dulaxetine HCl

Reaction Schemes
Stage I
S o d iu m h yd ro x id e
CH3
M .W t:4 0
N O
S D im e th yl s u lp h o x id e
O O
E th yl a c e ta te
E th y l a c e ta te .H C l
M .W t:1 2 4 .5
( S )- N -M e th yl- N -p h e n y lo x y c a rb o n yl-
3 -(1 - n a p th ylo x y) -3 -(2 -th ie n y l) p ro p yla m in e
M .W t: 4 1 7
H O
N
S CH3
O ONa C 2H 5C O O C H 3
O
.H y d ro c h lo ric a c id E th y l a c e ta te
+ +
M .W t: 8 8
S o d iu m p h e n yl
D u lo x e t in e H y d ro c h lo rid e c a rb o n a te
(P h a rm a ) M .W t: 1 6 0
M .W t: 3 3 3 .5
Stage I: (S)-N-Methyl-N-phenyloxycarbonyl-3-(1-napthyloxy)-3-(2-thienyl)propylamine is
resolved with sodium hydroxide in the presence of dimethyl sulfoxide to give (S)-N-
Methyl-3-(1-napthyloxy)-3-(2-thienyl)propylamine which is reacted with Ethyl
acetate.hydrochloric acid to yield Duloxetine hydchloride (Pharma). Process flow diagram
can be represented in Fig 2.6.Material balance can be presented in Table 2.9.
(S)-N-Methyl-N-phenyloxycarbonyl-3-
(1-napthyloxy)-3-(2-thienyl) propylamine (S)-N-Methyl-3-(1-napthyloxy)-
Dimethyl sulphoxide 3-(2-thienyl) propylamine
Sodium hydroxide Sodium phenyl carbonate

Base hydrolysisis
Ethyl acetate followed Dimethyl sulphoxide
Water by saltification Ethyl acetate
Activated carbon
Wastewater
Ethyl acetate.HCl
Duloxitene Hydrochloride
(Pharma)
Fig 2.6 Process Flow Diagram of Dulaxetine HCl

Table 2.9 Material Balance for Dulaxetine HCl

(Kg/day) (Kg/day)
(S)-N-Methyl-N-phenyl 242.7 Duloxetine HCl 166.7 Final Product
oxycarbonyl-3-(1-
napthyloxy)-3-(2-
thienyl)propylamine
Dimethyl sulphoxide 1722 Sodium Phenyl 80 Organic residue
(DMSO) carbonate
Sodium hydroxide flakes 38.3 Ethyl acetate 44 Recovery & reuse
Ethyl acetate 62.2 DMSO Recovered 1635.9 Recovery & reuse
Activated Carbon 20 DMSO Loss 13.8 Fugitive Loss
Water 1100 DMSO to Residue 72.3 Solvent in Residue
Ethyl acetate. HCl 20 Ethyl acetate 1140 Recovery & reuse
Recovered
Ethyl acetate 1200 Ethyl acetate Loss 9.6 Fugitive Loss
Hydrochloric acid 16.7 Ethyl acetate to 36 To Wastewater
wastewater
Ethyl acetate to 14.4 Solvent in Residue
Residue
(S)-N-Methyl-N- 34.2 Organic residue
phenyl oxycarbonyl-
3-(1-napthyloxy)-3-(2-
thienyl)propylamine
Ethyl acetate.HCl 20 To waste water
Activated Carbon 20 To spent carbon

2.1.7 Process Description of Esomeprazole Mg Trihydrate

Reaction Schemes
Stage I
O CH3
H3C C H3
O N O ( S ) - C a m p h o r s u lf o n y l c h lo r id e
C H3 M g C l2 2 H 2O
S + +
N N M .W t: 9 5 M .W t: 3 6 H yd ro g e n g a s (2 )
( + ) O m e p r a z o le
M .W t: 3 4 5
O C H3
H3C C H3
O N O 2H C l
C H3 +
S M .W t: 7 3
N N .M a g n e s iu m D ih y d r a t e
E s o m e p r a z o le m a g n e s iu m d ih y d r a t e ( P h a r m a )
M .W t: 4 0 5
Stage-I: (±) Omeprazole is resoluted with (S)-Camphor sulfonyl chloride and then treated
with magnesium chloride and water to yield Esomeprazole Magnesium Dihydrate
(Pharma). Process flow diagram is presented in Fig 2.7.Material balance is presented in
Table 2.10.
(+ ) O m e p r a z o le
H y d r o c h lo r ic a c id
M e th y le n e c h lo r id e
( S ) -C a m p h o r s u lfo n y l c h lo r id e M e th y le n e c h lo r id e
4 - D im e th y la m in o
4 - D im e th y la m in o p y r id in e
N ,N -D iis o p r o p y l e th y la m in e
A c e tic a c id N ,N -D iis o p r o p y l e th y la m in e
W a te r R e s o lu tio n A c e tic a c id
S o d iu m c h lo r id e
E th a n o l & E th a n o l
S o d iu m h y d r o x id e L y e S a ltfo r m a tio n A c e to n e
A c e to n e
M e th a n o l
M e th a n o l
P o ta s s iu m h y d r o x id e p o w d e r A c tiv a te d c a r b o n
M e g n e s iu m c h lo r id e
W a s te w a te r
H yd rogen gas
E s o m e p r a z o le m a g n e s iu m d ih y d r a te
(P h a r m a )
Fig 2.7 Process Flow Diagram of Esomeprazole Mg Trihydrate

Table 2.10 Material Balance for Esomeprazole Mg Dihydrate

(Kg/day) (Kg/day)
(±) Omeprazole 321.2 Esomeprazole Mg 333.3 Final Product
Dihydrate
Methylene dichloride 5472 Hydrogen Chloride 60.1 To scrubber
(MDC)
4-Dimethylamino pyridine 24 Methanol Recovered 1900 Recovery & reuse
N,N-Diisopropyl 40 Methanol Loss 16 Fugitive Loss
ethylamine
Camphour sulphonyl 15 Methanol to water 60 To Wastewater
chloride
Acetic acid 600 Methanol to Residue 24 Solvent in Residue
Ethanol 2000 MDC Recovered 5198.4 Recovery & reuse
Sodium hydroxide 150 MDC Loss 43.8 Fugitive Loss
Acetone 3000 MDC to Residue 229.8 Solvent in Residue
Methanol 2000 Acetic acid 570 Recovery & reuse
Recovered
Potassium hydroxide 12 Acetic acid Loss 4.8 Fugitive Loss
Magnesium chloride 88.4 Acetic acid to water 18 To Wastewater
Activated Carbon 30 Acetic acid to 7.2 Solvent in Residue
Residue
Hydrogen Gas 1.9 Ethanol Recovered 1900 Recovery & reuse
Water 4833.5 Ethanol Loss 16 Fugitive Loss
Hydrochloric acid 136.9 Ethanol to water 26 To Wastewater
Ethanol to Residue 58 Solvent in Residue
Acetone Recovered 2910 Recovery & reuse
Acetone to water 18.9 To Wastewater
Acetone to Residue 47.1 Solvent in Residue
(±) Omeprazole 37.3 Organic Residue
4-Dimethylamino 24 Organic Residue
pyridine
N,N-Diisopropyl 40 Organic Residue
ethylamine
Camphour 15 Organic Residue
sulphonyl chloride
Sodium Chloride 219 To waste water
Hydrogen 0.2 Let into atmosphere
through water column
Potassiumhydroxide 12 To Wastewater
Magnesium chloride 10.3 To Wastewater

2.1.8 Process Description of Glimepiride

Stage I
O O C H
S 3
O O N H 2
P o t a s s iu m c a r b o n a t e
H3C N N +
H T e tr a b u ty l A m m o n iu m
B r o m id e
H3C
N C O
4 - [ 2 - ( 3 - e t h y l- 4 - m e t h y l- 2 - o x o - 3 - p y r r o lin e - T ra n s -4 -m e th y l
1 - c a r b o x a m id o ) e t h y l] b e n z e n e s u lf o n a m id e c y c lo h e x y lis o c y a n a t e
M .W t : 3 5 1 M .W t : 1 3 9
O C H 3
O O
S
O O N N
H H
H3C N N
H
H3C
G lim e p ir id e (P h a rm a )
M .W t : 4 9 0
Stage- I: 4-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl] benzene
sulfonamide is condensed with Trans-4-methylcyclohexylisocyanate in presence of Tetra
butyl Ammonium Bromide to yield Glimipride (Pharma). Process flow diagram is
represented in Fig 2.8.Material balance is presented in Table 2.11.
T r a n s -4 -M e th y lc y c lo h e x y l is o c y a n a te
4 -[2 -(3 -e th y l-4 -m e th y l-2 -o x o -3 -p y r r o lin e -
1 -c a r b o x a m id o )e th y l]b e n z e n e s u lfo n a m id e
A c e to n e
A c e to n e
A c e tic a c id
A c e tic a c id
T e tr a b u ty l a m m o n iu m b r o m id e
D im e th y l fo r m a m id e
P o ta s s iu m c a r b o n a te
C o n d e n s a tio n
M e th y l is o b u ty l k e to n e
W a te r
M e th a n o l
D im e th y l fo r m a m id e
M e th y l is o b u ty l k e to n e W a s te W a te r
M e th a n o l
C e lite
G lim e p rid e
(P h a rm a )
Fig 2.8 Process Flow Diagram of Glimepiride

Table 2.11 Material Balance for Glimepiride

(Kg/day) (Kg/day)
4-[2-(3-ethyl-4-methyl-2- 145.8 Glimepiride 166.7 Final product
oxo-3-pyrroline-1-
carboxamido)
ethyl]benzene
sulfonamide
Trans-4-methylcyclohexyl 57.7 Acetone recovered 1176 Recovered and reused
isocyanate
Tetra butyl Ammonium 18 Acetone loss 6 Fugitive loss
Bromide (TBAB)
Acetic acid 20 Acetone to wastewater 4.2 To Wastewater
Acetone 1200 Acetone residue 13.8 Solvent in Residue
Dimethyl 500 DMF recovered 482.5 Recovered and reused
formamide(DMF)
Methanol 400 DMF loss 3 Fugitive loss
Potassium carbonate 32 DMF to wastewater 2.5 To Wastewater
Methyl Isobutyl 200 DMF residue 12 Solvent in Residue
Ketone(MIBK)
Activated carbon 10 Methanol recovered 392 Recovered and reused
DM water 1200 Methanol loss 2 Fugitive loss
Methanol to wastewater 1.4 To Wastewater
Methanol residue 4.6 Solvent in Residue
MIBK recovered 194 Recovered and reused
MIBK loss 1.4 Fugitive loss
MIBK residue 4.6 Solvent in Residue
4-[2-(3-ethyl-4-methyl-2- 26.4 Organic residue
oxo-3-pyrroline-1-
carboxamido) ethyl]
benzene sulfonamide
Trans-4-methyl 10.5 Organic residue
cyclohexyl isocyanate
TBAB 18 Organic residue
Acetic acid 20 To Wastewater
Activated carbon 10 To Spent carbon
Potassium carbonate 32 To Wastewater

2.1.9 Process Description of Mesalamine

Reaction Schemes
Stage I
Stage – I: Aniline reacts with Sodium nitrite in the presence of salicylic acid to form 5-
Phenylazosalicylicacid. 5-Phenylazosalicylicacid reacts with Sodium Hydrosulfide to form
Mesalamine.Process flow diagram presented in Fig 2.9.Material balance presented in Table
2.12.
Fig 2.9 Process Flow Diagram of Mesalamine

Table 2.12 Material Balance for Mesalamine

(Kg/day) (Kg/day)
Aniline 129 Mesalamine 166.7 Final Product
Sodium Nitrite 95 Aniline 101.4 Organic residue
Hydro Chloric acid 151 Nasulfo chloride 197.2 To waste water
Salicylic acid 191 Sodium chloride 63.7 To waste water
Sodium Hydro sulfide 155 Aniline 27.3 Organic residue
Carbon 20 Salicylic acid 40 To wastewater
Water 3600 Carbon 20 To spent carbon
Sodium hydroxide 35 Sodium Hydro sulfide 32.8 To Wastewater
Sodium Chloride 51.4 To Wastewater
Sodium Nitrite 20.2 Inorganic residue
2.1.10 Process Description of Metoprolol Succinate

Reaction Schemes
Stage I
O O
O
O
OH Cl NaCl H2 O
+
+
+ NaOH
+
M. Wt: 58.44 M. Wt: 18.02
M.Wt: 152.19 M. Wt: 92.52 M. Wt: 40.00
M.Wt: 208.25
Stage II
O
O
O OH
O
NH2
NH
O
M. Wt: 59.11
M.Wt: 208.25 Metoprolol
M. Wt: 267.36
Stage III
OH O OH
COOH
O COOH O
O CH2
CH2
CH2 NH CH2
NH
COOH COOH
Metoprolol 2
M. Wt: 118.09
M. Wt: 267.36
Metaprolol Succinate (pharma)
M. Wt: 652.81

Stage-I: The 4-(2-methoxyethyl) phenol and epichlorohydrin are mixed in aqueous media
like water are taken into a reactor. To this mixture 25% w/v sodium hydroxide is added. At
the end of the reaction, the aqueous and organic phases are separated out. The organic
phase is washed thrice by water.
Stage-II: The epoxide and isopropyl amine mixture is 2:1 volume: weight, is reacted in
aqueous media. On completion of reaction, the reaction mixture is cooled. The product is
then extracted using 3 volumes of toluene. The Toluene layer is washed with water for
removal of Isopropyl amine. The Toluene is distilled out at temperature 30 to 40° C. under
vacuum. The residue of Metoprolol base so obtained shows a purity of greater than 99%.
Stage-III: The metoprolol base is dissolved in Acetone. Succinic acid solution is added to
Metoprolol base solution and refluxed. After refluxing, the mixture is then cooled to obtain
metoprolol succinate salt, which is purified by crystallization from three volumes of
Methanol. Process flow diagram of metoprolol succinate is shown in Fig 2.10 and material
balance for metoprolol succinate is presented in Table 2.13.

Fig 2.10 Process Flow Diagram of Metoprolol Succinate

Table 2.13 Material Balance for Metoprolol Succinate

Stage I
(Kg/day) (Kg/day)
4-(2-Methoxy-ethyl)- 267.6 2-[4-(2-Methoxy-ethyl)- 357.4 To Stage-II
phenol phenoxymethyl]-oxirane
2-Chloromethyl- 162.7 Sodium chloride 102.8 To wastewater
oxirane
70.3 4-(2-Methoxy-ethyl)- 6.4 Organic residue
Sodium hydroxide
phenol
Water 2000 2-Chloromethyl-oxirane 3.9 Organic residue
Hydrochloric acid 2 Sodium chloride 2.5 To wastewater
Water 2031.7 To wastewater
Stage II
(Kg/day) (Kg/day)
Stage I Product 357.4 Metoprolol 445.1 To Stage-III
Isopropyl amine 101.5 Toluene Recovered 970 Recovery & reuse
Toluene 1000 Toluene Loss 3 Fugitive Loss
Water 1300 Toluene to wastewater 5.2 To Wastewaetr
Isopropyl amine 3 Organic residue
Water 1300 To wastewater
Stage III
(Kg/day) (Kg/day)
Metoprolol 445.1 Metoprolol Succinate 500 Final Product
Succinic acid 98.4Acetone Recovered 2425 Recovery & reuse
Acetone 2500 Acetone Loss 12.5 Fugitive Loss
Acetone in residue 63 Solvent in residue
Metoprolol 35.61 Organic residue
Succinic acid 7.87 Organic residue

2.1.11 Process Description of Pantoprazole sodium sesquihydrate

Reaction Schemes
F F O C H 3
C H 3 O D iis o p r o p y l e t h e r
O N N aO C l N aO H 2 H 2 O
S C + + +
N S o d iu m h y p o c h lo r it e M .W t: 3 6 E th a n ol
N H 2
M .W t: 4 0
H M .W t: 7 4 .5
5 - ( D if lu o r o m e th o x y ) - 2 - [[( 3 ,4 - d im e th o x y - 2 -
p y r id in y l) m e t h y l] t h io ] - 1 H - b e n z im id a z o le
M .W t: 3 6 7
F F O M e
M eO
N aC l 1 .5 H O
O N O 2
. 1 .5 H 2 O + +
S M .W t: 5 8 .5 M .W t: 2 7
N
N -
+
N a
P a n to p ra z o le s o d iu m s e s q u ih y d ra te
(P h a rm a )
M .W t: 4 3 2
Stage I
5-(Difluoromethoxy)-2-[[3,4-dimethoxy-2-pyridinyl)methyl]thio]-1H-benzimidazole(Stage-I
compound) is Oxidised with Sodium Hypochlorite, then reacted with Sodium hydroxide
and water in presence of Methylene dichloride and Diisopropyl ether to give Pantoprazole
sodium sesquihydrate (Pharma). Process flow diagram Presented in Fig 2.11.Material
balance presented in Table 2.14.
5 - ( D i f l u o r o m e t h o x y ) - 2 - [ [ 3 ,4 -
d i m e th o x y - 2 - p y r id in y l )
m e t h y lt h i o ] - 1 H - b e n z i m i d a z o l e
N aC l
S o d iu m h y p o c h lo r ite
M e th y l e n e c h lo r id e
A m m o n i u m s u lp h a t e
M e t h y le n e c h l o r i d e D iis o p r o p y l e th e r
O x id a tio n
D iis o p r o p y l e th e r & A c e to n e
S a ltific a tio n
A c e to n e E th a n o l
E th a n o l
A c t iv a t e d c a r b o n A c t iv a t e d c a r b o n
S o d i u m h y d r o x i d e ly e
W a ste w a te r
W a te r
P a n to p r a z o le S o d iu m S e s q u ih y d r a te
(P h a rm a )
Fig 2.11 Process Flow Diagram of Pantoprazole sodium Sesquihydrate

Table 2.14 Material Balance for Pantoprazole Sodium Sesquihydrate

(Kg/day) (Kg/day)
5-(Difluoromethoxy)-2- 459.2 Pantoprazole Sodium 500 Final Product
[[3,4-dimethoxy-2- Sesquihydrate
pyridinyl) methyl]thio]-
1H-benzimidazole
Sodium hypochlorite (8%) 1165.2 Acetone Recovered 873 Recovery & reuse
Sodium hydroxide flakes 200.1 Acetone Loss 7.2 Fugitive Loss
Ammonium sulphate 250 Acetone to water 5.7 To Wastewater
Diisopropyl ether (DiPE) 1500 Acetone to Residue 14.1 Solvent in Residue
Ethanol 1200 Ethanol Recovered 1164 Recovery & reuse
Activated carbon 30 Ethanol Loss 9.6 Fugitive Loss
Acetone 900 Ethanol to water 7.6 To Wastewater
Water 3445 Ethanol to Residue 18.8 Solvent in Residue
Methlene Dichloride 250 MDC Recovered 237.5 Recovery & reuse
(MDC)
Hydrochloric acid 140.3 MDC Loss 2 Fugitive Loss
MDC to water 0.8 To Wastewater
MDC to Residue 9.7 Solvent in Residue
DiPE Recovered 1452 Recovery & reuse
DiPE Loss 12 Fugitive Loss
DiPE to water 12.5 To Wastewater
DiPE to Residue 23.6 Solvent in Residue
Organic Impurities 34.4 Organic residue
Activated carbon 30 To spent carbon
Sodium hypochlorite 7 To Wastewater
Ammonium sulphate 250 Inorganic Residue
Sodium chloride 292.6 To Wastewater

2.1.12 Process Description of Pragabalin

Reaction Schemes
Stage I
CONH2 NH2
O Chloroform O
+ NaOCl + H2O
+ H2CO3 + NaCl
OH OH
3-(Carbamoylmethyl)-5- Sodium hypochlorite Water Pregabalin Carbonic acid Sodium chloride
methylhexanoic acid M.Wt 74.5 M.Wt 18 M.Wt 62 M.Wt: 58.5
M.Wt 159
M.Wt 187
3-(Carbamoylmethyl)-5-methylhexanoic acid is reacted with sodium hypochlorite to give
Pregabalin (Pharma). The process flow diagram is presented in fig 2.12. The material balance
is shown in Table 2.15.
3-(Carbamoylmethyl)-
5-methylhexanoic acid
Carbonic acid
Chloroform
Chloroform
Phenylethylamine
Sodium chloride
Sodium hypochlorite
Sodium hydroxide
Hydrochloric acid
Isopropyl alcohol Isopropyl alcohol
Water Waste water
Pregabalin(Pharma)
Fig 2.12 Process Flow Diagram of Pragabalin

Table 2.15 Material Balance for Pragabalin

(Kg/day) (Kg/day)
3-(Carbamoylmethyl)-5- 817.9 Pregabalin 500 Final Product
methylhexanoic acid
Phenylethylamine 75
Carbonic acid 195 To wastewater
Sodium hypochlorite 325.8
Sodium chloride 184 To wastewater
Hydrochloric acid 20
IPA Recovered 1900 Recovery & reuse
Sodium hydroxide 21.9
IPA Loss 16 Fugitive Loss
Isopropanol (IPA) 2000
IPA to water 60 To Wastewater
Chloroform 4000
Water 78.7
Chloroform Recovered 3800 Recovery & reuse
Water 3500
Chloroform Loss 32 Fugitive Loss
Chloroform to water 120 To Wastewater
Chloroform to Residue 48 Solvent in Residue
3-(Carbamoylmethyl)-5- 229.8 Organic residue
methylhexanoic acid
Phenylethylamine 75 Organic residue
Sodium hypochlorite 92 To Wastewater
2.1.13 Process Description of Rosuvastatin Calcium

Reaction Schemes
Stage I
H3C CH3
O OH
COOMe
2. O O N
2 N aBH 4 2 N aO H C a (O C O C H 3)2
S 6 H 2O
H3C N N
+ S o id u m b o r o h y d r id e + + S o d iu m H y d r o x id e + C a lc iu m a c e t a t e
M .W t: 1 0 8
C H3
F M .W t: 7 4 M .W t: 8 0 M .W t: 1 5 8
( R ) - 7 - [ 4 - ( 4 - F lu o r o p h e n y l) - 6 - ( 1 - m e t h y le t h y l) - 2 -
[ m e t h y l( m e t h y ls u lf o n y l) a m in o ] - 5 - p y r im id in y l] - 3 -
h y d r o x y - 5 - o x o - 6 - h e p t e n o ic a c id m e t h y l e s t e r
M .W t: 9 8 7
2 N aO CH 3
S o d iu m m e t h o x id e
M .W t: 1 0 8
E th a n o l
H3C CH3 C a 2+ 2 N aBO
OH OH O 3
S o d iu m p e r b o r a t e
N O
O O
W a te r M .W t: 1 6 2
S
N
+
H3C N
A c e to n e
CH3
F 2 C H 3C O O H
2
A c e t ic a c id
R o s u v a s t a t in C a lc iu m ( P h a rm a ) M .W t: 1 2 0
M .W t: 1 0 0 1
8H 2
M .W t: 1 6

(R)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidin
yl]- 5-pyrimidinyl]-3-hydroxy-5-oxo-6-heptenoic acid methyl ester is reduced by using
sodiumborohydride, followed by hydrolised with sodium hydroxide in acetone and water
and then treated with calcium acetate in ethanol to yield Rosuvastatin calcium (Pharma).
The process flow diagram for Rosuvastatin calcium is presented in Fig 2.13 .Material balance
is presented in Table 2.16.
(R)-7-[4-(4-Fluorophenyl)-6-(1-m ethyl
ethyl)-2-[m ethyl(m ethylsulfonyl)am ino]-
5-pyrim idinyl]-3-hydroxy-5-oxo- Sodium m ethoxide
6-heptenoic acid m ethyl ester
Soidum borohydride
Sodium perborate
Sodium H ydroxide
A cetone
W ater
Ethyl acetate
A cetone
A cetic acid
Ethyl acetate
A ctivated C arbon A ctivated C arbon
C alcium acetate Ethanol
Ethanol
W astew ater
W ater
Rosuvastatin C alcium (Pharm a)
Fig 2.13 Process Flow Diagram of Rosuvastatin Calcium

Table 2.16 Material Balance for Rosuvastatin Calcium

(Kg/day) (Kg/day)
(R)-7-[4-(4-Fluorophenyl)- 114.7 Rosuvastatin Calcium 100 Final Product
6-(1-methylethyl)-2-
[methyl(methylsulfonyl)
amino]-5-pyrimidinyl]-5-
pyrimidinyl]-3-hydroxy-
5-oxo-6-heptenoic acid
methyl ester
Sodium borohydride 8.6 Sodium Methoxide 10.8 Organic residue
Sodium hydroxide 9.3 Sodium Perborate 16.2 To wastewater
Water 12.5 Acetic acid 12 To Wastewater
Acetone 750 Hydrogen 1.6 Let out into
atmosphere
through water
column
Ethyl acetate 1000 Acetone Recovered 720 Recovery & reuse
Activated carbon 25Acetone Loss 6 Fugitive Loss
Calcium acetate 18.4Acetone to wastewater 5.5 To Wastewater
Ethanol 800 Acetone to Residue 18.5 Solvent in Residue
Water 1100 Ethyl acetate Recovered 980.0 Recovery & reuse
Hydrochloric acid 1.2Ethyl acetate Loss 8.0 Fugitive Loss
Ethyl acetate to 9.3 To Wastewater
wastewater
Ethyl acetate to Residue 2.7 Solvent in Residue
Ethanol Recovered 768 Recovery & reuse
Ethanol Loss 6.4 Fugitive Loss
Ethanol to wastewater 6.6 To Wastewater
(R)-7-[4-(4-Fluorophenyl)- 16.1 Organic residue
6-(1-methylethyl)-2-
[methyl(methylsulfonyl)
amino]-5-pyrimidinyl]-5-
pyrimidinyl]-3-hydroxy-
5-oxo-6-heptenoic acid
methyl ester
Calcium acetate 2.6 To Wastewater
Sodium borohydride 1.2 To Wastewater
Sodium Chloride 1.9 To Wastewater

2.1.14 Process Description of Sertraline HCl

Reaction Schemes
Stage I
N CH3
N aBH 4 4 C H 3O H D - ( - ) M a n d e lic a c id
S o d iu m +
+ B o r o h y d r id e
M e th a n o l
HCl
M .W t: 1 2 8
M .W t: 3 8 M .W t:3 6 .5
Cl
Cl
N H - C H 3 .H C l
4 - ( 3 , 4 - D ic h lo r o p h e n y l) - 3 , 4 -
d ih y d r o - N - m e t h y l- 1 ( 2 H ) -
N a p h t h a le n im in e
B (O C H 3)3 N aO C H 3
3 H
M .W t:3 0 4 + T r im e t h o x y + S o d iu m + 2
b o ra n e M e t h o x id e M .W t: 6
M .W t: 1 0 4 M .W t: 5 4
Cl
Cl
S e rtra lin e H y d ro c h lo rid e
(P h a rm a )
M .W t:3 4 2 .5
4-(3,4-Dichlorophenyl)-3,4-dihydro-N-methyl-1(2H)-Naphthalenimine is hydrogenated with
sodium borohydride followed by resolution with D-(-) Mandelic acid and then treated with
Hydrochloric acid to give Sertraline hydrochloride (Pharma). Process flow diagram is
presented in Fig 2.14.Material balance is presented in Table 2.17.
4-(3,4-Dichlorophenyl)-3,4-dihydro-
N-methyl-1(2H)-Naphthalenimine
Methanol Trimethyl borate
Sodium borohydride
Activated carbon Sodium methoxide
Reduction
HCl
& H2
Water
Diisopropyl Ether
Resolution Activated carbon
Ethyl acetate
Waste water
D-(-)-Mandelic acid
NaCl
n-Butanol
NaOH
Sertraline HCl
(Pharma)
Fig 2.14 Process Flow Diagram of Sertraline HCl

Table 2.17 Material Balance for Sertraline HCl

(Kg/day) (Kg/day)
4-(3,4-Dichlorophenyl)- 378.8 Sertraline Hydrochloride 333.3 Final Product
3,4-dihydro-N-methyl-
1(2H)-Naphthalenimine
Sodium Borohydride 47.3 Trimethoxy Borane 101.2 To wastewater
Methanol 159.5 Sodium methoxide 52.5 Carried with
methanol in
Organic residue
Hydrochloric acid 45.5 Hydrogen 5.8 Let out into
atmosphere
Ethyl acetate 3000 Ethyl acetate Recovered 2850 Recovery & reuse
Activated carbon 20 Ethyl acetate Loss 24 Fugitive Loss
D-(-)-Mandelic acid 85 Ethyl acetate to water 90 To Wastewater
Sodium hydroxide lye 10.9 Ethyl acetate to Residue 36 Solvent in Residue
Water 3500 n-Butanol Recovered 1425 Recovery & reuse
n-Butanol 1500 n-Butanol Loss 12 Fugitive Loss
Diisopropyl ether 650 n-Butanol to water 45 To Wastewater
(DiPE)
n-Butanol to Residue 18 Solvent in Residue
DiPE Recovered 617.5 Recovery & reuse
DiPE Loss 5.2 Fugitive Loss
DiPE to water 19.5 To Wastewater
4-(3,4-Dichlorophenyl)- 83 Organic residue
3,4-dihydro-N-methyl-
1(2H)-Naphthalenimine
Activated carbon 20.0 To spent carbon
D-(-)-Mandelic acid 85 To waste water
Methanol 35 To Organic Waste
Sodium Borohydride 10.4 To Wastewater
Sodium chloride 16 To Wastewater

2.1.15 Process Description of Tramadol Hydrochloride

Reaction Schemes
Stage I

Stage I
2-[(N,N-Dimethylamino)methyl]cyclohexanone is reacted with Bromo (3-methoxy phenyl)

magnesium in presence of Sodium carbonate in Ethyl acetate, n-Propanol and water to yield
Tramadol Hydrochloride (Pharma). The process flow diagram for Tramadol Hydrochloride
is presented in Fig 2.15.Material balance is presented in Table 2.18.
Fig 2.15 Process Flow Diagram of Tramadol Hydrochloride

Table 2.18 Material Balance for Tramadol Hydrochloride

(Kg/day) (Kg/day)
2-[(N,N-Dimethylamino) 461.9 Tramadol HCl 666.7 Final Product
methyl] cyclohexanone
Bromo(3-methoxyphenyl) 628.8 Hydroxy MgBr 269.4 Inorganic residue
magnesium
Sodium carbonate 170 n-Propanol Recovered 2850 Recovery & reuse
Ethyl acetate 3500 n-Propanol Loss 24 Fugitive Loss
Hydrochloric acid 258.8 n-Propanol to water 90 To Wastewater
n-Propanol 3000 n-Propanol to Residue 36 Solvent in Residue
Activated carbon 30 Ethyl acetate Recovered 3325 Recovery & reuse
Water 53.6 Ethyl acetate Loss 28 Fugitive Loss
Water 6000 Ethyl acetate to water 105 To Wastewater
Sodium Hydroxide 194.5 Ethyl acetate to Residue 42 Solvent in Residue
2-[(N,N-Dimethyl 116.9 Organic residue
amino) methyl]
cyclohexanone
Bromo(3-methoxy 159 Organic residue
phenyl) magnesium
Sodium chloride 285 To Wastewater
Sodium carbonate 170 To Wastewater

2.1.16 Process Description of Valaciclovir Hydrochloride monohydrate

Reaction Schemes
Stage I
O
O W a te r ( 1 8 )
N HOOC N Ph
HN 4 0 % D im e th y l a m in e
O
+
AcHN N N O
OAc H3C CH3 D im e th y l f o r m a m id e
4 - D im e th y la m in o p y r id in e
1 , 3 - D ic y c lo h e x y l c a r b o d im id e
2 - ( A c e ty la m in o ) - 1 ,9 - d ih y d r o - 9 - C a r b o b e n z y lo x y - L - v a lin e
[[2 - ( a c e ty lo x y ) e th o x y ]m e t h y l]-
6 H - p u r in - 6 - o n e M .W t : 2 5 1
M .W t: 3 0 9
O
HN N O
H2N N N HN O Ph + 2 C H 3C O O H
O C H3 M .W t: 1 2 0
O
O CH3
2 - [( 2 - A m in o - 1 ,6 - d ih y d r o - 6 - o x o - 9 H - p u r in -
9 - y l) m e t h o x y ]e th y l N - [( b e n z y lo x y ) c a r b o n y l]
L - v a lin e
M .W t: 4 5 8
Stage II
O
HN N O
H 2 , P d /C
N HN O Ph + HCl + H 2O
H2N N M .W t: 2
O CH3 M .W t: 3 6 .5 M .W t: 1 8
O
O CH3
2 -[( 2 -A m in o -1 ,6 -d ih yd ro -6 -o x o - 9 H - p u rin -
9 -yl)m e th o x y]e th yl N -[( b e n z ylo x y)c a rb o n yl]
L -v a lin e
M .W t: 4 5 8 O
HN N
H2N N N NH2 Ph COOH

O CH3
+
O P h e n yla c e tic a c id
.H Cl .H2O
O CH3 M .W t: 1 3 6
V a lc ic lo v ir H y d ro c h lo rid e m o n o h y d ra te (P h a rm a )
M .W t: 3 7 8 .5
Process Description
Stage-I: 2-(Acetylamino)-1,9-dihydro-9-[[2-(acetyloxy)ethoxy]methyl]-6H-purin-6-one
condensed with carbobenzyloxy–L–valine in the presence of 40% Dimethyl
amine,Dimethylformamide, 4-Dimethylamino pyridine and 1, 3-Dicyclohexyl carbodimide

to yield 2-[(2-Amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl N-
[(benzyloxy)carbonyl] L-valine (Stage-I compound).
Stage-II: 2-[(2-Amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethylN-[(benzyloxy)
carbonyl] L-valine is reduced with H2 using palladium on carbon as catalysed and further
reacted with Hydrochloric acid and water to yield Valaciclovir Hydrochloride
Monohydrate (Pharma). Processw flow diagram is presented in Fig 2.16.Material balance is
presented in Table 2.19.
2-(Acetylamino)-1,9-dihydro-9- 2-[(2-Amino-1,6-dihydro-6-oxo-9H-
[[2-(acetyloxy)ethoxy]methyl]- purin-9-yl)methoxy]ethyl]N-[(benzyl
6H-purin-6-one oxy)carbonyl] L-valine
Carbobenzyloxy-L-Valine Acetic acid
Dimethyl amine Dimethyl
Dimethyl formamide STAGE-I Dimethyl formamide
4-Dimethylamino pyridine 4-Dimethylamino pyridine
1,3-Dicyclohexyl carbodimide 1,3-Dicyclohexyl carbodimide
Condensation
Acetone Acetone
Water Wastewater
Hyflo super cel Hyflo super cel
Ethanol Ethanol
2-[(2-Amino-1,6-dihydro-6-oxo-9H-
purin-9-yl)methoxy]ethyl]N-[(benzyl
oxy)carbonyl] L-valine Phenylacetic acid
Palladium on carbon
Palladium on carbon
Water
STAGE-II
Hydrochloric acid Wastewater
Methanol
Reduction
Methanol
Ethanol
Hydrogen gas Ethanol
Sodium hydroxide
Valcyclovir Hydrocloride
Monohydrate (Pharma)
Fig 2.16 Process Flow Diagram of Valaciclovir Hydrochloride monohydrate

Table 2.19 Material Balance for Valaciclovir Hydrochloride Monohydrate

Stage I
(Kg/day) (Kg/day)
2-(Acetylamino)-1,9- 494.4 Stage I Product 669.72 Stage II Product
dihydro-9-[[2-
(acetyloxy)ethoxy]
methyl]-6H-purin-6-one
Carbenzyloxy-L-Valine 402 Acetic acid 175.5 To Wastewater
Dimethyl amine (DMA) 2500 DMA Recovered 2437.5 Recoverd & Reused
Dimethyl formamide 350 DMA Loss 12.5 Fugitive Loss
(DMF)
4-Dimethylamino 20 DMA to Wastewater 25 To Wastewater
pyridine
1,3-Dicyclohexyl 100 DMA to Residue 25 Solvent in Residue
carbodiimide
Acetone 2500 DMF Recovered 339.3 Recoverd & Reused
Water 29 DMF Loss 1.4 Fugitive Loss
Hyflo super cel 15 DMF to Residue 9.1 Solvent in Residue
Ethanol 3000 Acetone Recovered 2437.5 Recoverd & Reused
Sodium hydroxide 150 Acetone Loss 10 Fugitive Loss
Water 2500 Acetone to Residue 52.5 Solvent in Residue
Hydrochloric acid 136.9 Ethanol Recovered 2925 Recoverd & Reused
Ethanol Loss 12 Fugitive Loss
2-(Acetylamino)-1,9- 42.6 Organic Residue
dihydro-9-[[2-
(acetyloxy)ethoxy]
methyl]-6H-purin-6-
one
Carbenzyloxy-L-Valine 34.6 Organic Residue
4-Dimethylamino 20 Organic Residue
pyridine
1,3-Dicyclohexyl 100 Organic Residue
carbodiimide
Hyflo super cel 15 Inorganic residue

Stage II
(Kg/day) (Kg/day)
Stage I Product 669.7 Valcyclovir 333.3 Final Product
Hydrochloride
Monohydrate
Palladium on carbon 30 Phenyl acetic acid 119.8 To Wastewater
Water 26.3 Methanol Recovered 1447.5 Recoverd & Reused
Hydrochloric acid 53.4 Methanol Loss 7.5 Fugitive Loss
Methanol 1500 Methanol to 15 To Wastewater
Wastewater
Ethanol 2500 Methanol to Residue 30 Solvent in Residue
Hydrogen 2.9 Ethanol Recovered 2412.5 Recoverd & Reused
Activated Carbon 25 Ethanol Loss 12.5 Fugitive Loss
Water 3000 Ethanol to Wastewater 20 To Wastewater
Sodium Hydroxide 23.3 Ethanol to Residue 55 Solvent in Residue
Activated Carbon 25 To spent carbon
Palladium on carbon 30 To spent catalyst
water 3021 To waste water
Hydrogen 1.2 Let out into
atmosphere
Sodium Chloride 34 To waste water

2.1.17 Process Description of 4-[4-Chloro-1-oxobutyl]-2, 2- dimethyl phenyl acetic acid

methyl ester
Reaction Schemes
Stage I
Stage II
Stage III

Process Description
Stage-I: 2-methyl-2-phenyl propan-1-ol reacts with acetyl chloride in presence of sodium
acetate AlCl3, DMF and toluene to give Acetic acid 2-methyl-allyl ester (Stage-I compound).
Stage-II: Acetic acid 2-methyl-2-phenyl-propyl ester is react with 4- chloro butyryl chloride
in presence of AlCl3 to give Acetic 2-[4-(4-chloro-butyryl)-phenyl]-2-methyl-propyl ester.
Further this is react with NaOH to give Cyclopropyl-[4-(2-hydroxy-1, 1-dimethyl-ethyl)-
phenyl]-methanone (Stage-II compound).
Stage-III: Cyclopropyl-[4-(2-hydroxy-1, 1-dimethyl-ethyl)-phenyl]-methanone is react with

KMO4 to give 2-(4-Cyclopropanecarbonyl-phenyl)-2-methyl-propionoc acid. Further this is
reacting with Methanol and HCl to give 4- (4-Chloro-1-oxobutyl) 2, 2-dimethylphenyl acetic
acid methyl ester (Stage-III compound). The process flow diagram for give 4- (4-Chloro-1-
oxobutyl) 2, 2-dimethylphenyl acetic acid methyl ester is presented in Fig 2.17. And
material balance is presented in Table 2.20.


Fig 2.17 Process Flow Diagram of 4-[4-Chloro-1-oxobutyl]-2, 2- dimethyl phenyl acetic acid
methyl ester

Table 2.20 Material Balance for 4-[4-Chloro-1-oxobutyl]-2, 2- dimethyl phenyl acetic acid
methyl ester
Stage I
(Kg/day) (Kg/day)
2-methyl-2-phenyl 122.6 Stage I Product 122.6 To Stage-II
propan-1-ol
Acetyl chloride 64DMF Recovered 232 Recovery & reuse
Sodium acetate 65DMF Loss 0.5 Fugitive Loss
DMF 241.5DMF to Wastewater 2.4 To wastewater
Toluene 400 DMF to Residue 6.8 Solvent in Residue
Water 2500 Toluene Recovered 384 Recovery & reuse
Aluminium chloride 85 Toluene Loss 0.8 Fugitive Loss
5 % sodium bi carbonate 100 Toluene to Wastewater 4 To wastewater
Sodium Hydroxide 25.5Toluene to Residue 11.2 Solvent in Residue
2-methyl-2-phenyl 26.8 Organic residue
propan-1-ol
Acetyl chloride 14 Organic residue
Sodium acetate 65 To wastewater
Aluminium chloride 85 To wastewater
Sodium bi carbonate 5 To wastewater
Sodium chloride 37.2 To wastewater
Stage II
(Kg/day) (Kg/day)
Stage I Product 122.6 Stage II Product 111.1 To Stage-III
4-chloro butyryl chloride 89.9 Aluminium chloride 68 To Waste water
Aluminium chloride 85 Acetic acid 30.9 To Waste water
Sodium hydroxide flakes 25.5 Sodium chloride 29.8 To Waste water
Methylene dichloride 800.0 MDC Recovered 776 Recovery & reuse
(MDC)
Diluted Hcl 4.7 MDC Loss 2 Fugitive Loss
Methanol 600 MDC to Residue 22 Solvent in Residue
5 % sodium bi carbonate 100 Toluene Recovered 533.5 Recovery & reuse
Toluene 550 Toluene Loss 1.4 Fugitive Loss
Water 1500 Toluene to Residue 15.1 Solvent in Residue
Methanol Recovered 582 Recovery & reuse
Methanol Loss 1.5 Fugitive Loss
4-chloro butyryl 18 Inorganic residue
chloride
Aluminium chloride 17 To Waste water
Sodium Chloride 7.5 To Waste water

Sodium bi carbonate 5 To Waste water

Water 1597.3 To Waste water
Stage III
(Kg/day) (Kg/day)
Stage II Product 111.1 4-(4-Chloro-1- 100 Final Product
oxobutyl)2,2-dimethyl
phenyl acetic acid
methyl ester
Potassium Permanganate 80.4 Potassium Manganite 44.6 Inorganic residue
MDC Recovered 145.5 Recovery & reuse
Methanolic HCl 35 MDC Loss 0.4 Fugitive Loss
Sodium hydroxide flakes 95 MDC to Residue 4.1 Solvent in Residue
Con. Hydrochloric acid 86.7 Toluene Recovered 679.0 Recovery & reuse
Sodium meta bisulfite 40 Toluene Loss 1.8 Fugitive Loss
10% C. lye solution 200 Toluene to Residue 19.3 Solvent in Residue
Methylene dihloride 150 Stage II Product 33.9 Organic residue
(MDC)
Toluene 700 Methanolic HCl 10.6 To waste water
Water 2500 Potassium 24.5 To waste water
Permanganate
Sodium chloride 138.8 To waste water
Sodium meta bisulfite 40 Inorganic residue
Water 2735.5 To waste water

2.1.18 Process Description of N2-(1-(S)-ethoxy carbonyl-3-phenyl propyl-N6-trifluoro acetyl-

L-lysine
Reaction Schemes
Stage I
Stage II
Process Description
Stage-I: L-Lysine is reacted with 2, 2, 2-Trifluoroethylacetate in presence of methanol and
water to give (S)-6-(2, 2, 2-trifluoroacetamido-2-amino hexanoicacid.
Stage-II: (E)-Ethyl-4-oxo-4-phenylbut-2-enoate and (S)-6-(2,2,2-trifluoroacetamido-2-amino

hexanoicacid are reacted in presence of lithium hydroxide and HCl and further reacted with
Pd/C under hydrogen atmosphere in presence of ethanol, ethyl acetate and Water to give
N2-(1-(S)-ethoxycarbonyl-3-phenylpropyl-N6-trifluoro acetyl) -L- Lysine.process flow
diagram is presented in Fig 2.18.Material balance is presented in Table 2.21.

Fig 2.18 Process Flow Diagram of N2-(1-(S)-ethoxy carbonyl-3-phenyl propyl-N6-trifluoro

acetyl-L-lysine

Table 2.21 Material Balance for N2-(1-(S)-ethoxy carbonyl-3-phenyl propyl-N6-trifluoro

acetyl-L-lysine
Stage I
(Kg/day) (Kg/day)
L-Lysine 319.5 Stage I Product 303.5 To Stage II
Water 1200 Ethanol 57.7 To Wastewater
Caustic Lye (40%) 80 Methanol Recovered 2316 Recoverd & Reused
2,2,2-Trifluoroethyl 310.8 Methanol Loss 12 Fugitive Loss
acetate
Methanol 2400 Methanol to Wastewater 24 To Wastewater
L-Lysine 136.4 Organic Residue
2,2,2-Trifluoroethylacetate 132.7 Organic Residue
Caustic Lye 32 To Waste water
Water 1248 To waste water
Stage II
(Kg/day) (Kg/day)
Stage I Product 303.5 N2-(1-(S)-ethoxycarbonyl- 166.7 Final Product
3-phenylpropyl- N6-
trifluoro acetyl)- L-Lysine
(S)-6-(2,2,2- 360 Lithium chloride 16.4 To Wastewater
trifluoroacetamido-2-
amino hexanoicacid
Ethanol 100 Ethyl acetate Recovered 1930 Recoverd & Reused
Lithium Hydroxide 35.7 Ethyl acetate Loss 10 Fugitive Loss
Hydrochloric acid 54.3 Ethyl acetate to water 12.2 To Wastewater
Palladium on catalyst 50 Ethyl acetate to Residue 47.8 Solvent in Residue
Water 1500 Ethanol Recovered 97 Recoverd & Reused
Ethylacetate 2000 Ethanol Loss 0.4 Fugitive Loss
Hydrogen 6 Ethanol to Wastewater 0.5 To Wastewater
Caustic Lye (40%) 110.2 Ethanol to Residue 2.1 Solvent in Residue
(S)-6-(2,2,2-trifluoro 266.6 Organic Residue
acetamido- 2-amino
hexanoicacid
Lithium Hydroxide 26.4 To Wastewater
Palladium on catalyst 50 To spent catalyst
Hydrogen Gas 4.4 Let out into
atmosphere through
water column

2.1.19 Process Description of 2-[2-[3(S)-[3-[2-(7-Chloro-2-Quinolinyl)-ethenyl] phenyl]-3-

hydroxypropyl] phenyl-2-propanol
Reaction Schemes
Stage I
Stage II

Stage–I: 3-[2-(7-chloro-2-quinolinyl)ethenyl]-alpha-[2-(methoxycarbonyl-phenyl)methyl] -
beta-oxo-benzene propanoicacid methyl ester react with hydrochloric acid in presence Of
Acetic acid to give 2-[3-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-
(oxopropyl]benzoicacid and this under goes to reacted with methyl Iodide to gives 2-[3-[3-
[2-(7-chloro-2-quinolinyl)ethenyl]-phenyl]-3-(oxopropyl]benzoic acid methyl ester.
Stage–II: 2-[3-[3-[2-(7-chloro-2- quinolinyl)ethenyl] phenyl]-3-(oxopropyl] benzoic acid

methyl ester react with (-)-beta chlorodiisopinocamphenyl borane and methanol to give (S)-
2-[3-[3-[2-7-chloro-2-quinolinyl)ethenyl] phenyl]-3-hydroxypropyl]benzoic acid methyl ester
and this under goes to reacted with methyl magnesium chloride and water in toluene to
give 2-[2--[3(S)-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-hydroxypropyl] phenyl]-2-
propanol.Process Flow diagram presented in Fig 2.19.Material balance presented in Table
2.22.

Fig 2.19 Process Flow Diagram of 2-[2-[3(S)-[3-[2-(7-Chloro-2-Quinolinyl)-ethenyl] phenyl]-

3-hydroxypropyl] phenyl-2-propanol

Table 2.22 Material Balance for 2-[2-[3(S)-[3-[2-(7-Chloro-2-Quinolinyl)-ethenyl]phenyl]-3-

Stage I
(Kg/day) (Kg/day)
3-[2-(7-chloro-2-quinolinyl) 146.2 Stage I Product 120.5 To Stage II
ethenyl]-alpha-[2-(methoxy
carbonyl-phenyl)methyl] -
beta-oxo-benzenepropanoic
acid methyl ester
Glacial acetic acid 150 Methanol 16.9 To Wastewater
Hydrochloric acid 10.4 Carbon dioxide 11.6 Let out into
atmosphere
Methyl iodide 40.1 Hydrogen Iodide 33.8 To Wastewater
Saturated ammonium 600 Methanol Recovered 144.8 Recoverd & Reused
chloride (20%)
Methylene Dichloride (MDC) 2500 Methanol Loss 0.8 Fugitive Loss
Potassium Carbonate 25 Methanol to water 1.5 To Wastewater
Methanol 150 Methanol to 3 Solvent in Residue
Residue
Water 1300 MDC Recovered 2412.5 Recoverd & Reused
Acetonitrile 400 MDC Loss 12.5 Fugitive Loss
Sodium Hydroxide 0.8 MDC to water 5.3 To Wastewater
MDC to Residue 69.8 Solvent in Residue
Acetonitrile 386 Recoverd & Reused
Recovered
Acetonitrile Loss 2 Fugitive Loss
Acetonitrile to water 0.4 To Wastewater
Acetonitrile to 12 Solvent in Residue
Residue
3-[2-(7-chloro-2- 10.2 Organic residue
quinolinyl)ethenyl]-
alpha-[2-(methoxy
carbonyl-phenyl)
methyl] -beta-oxo-
benzenepropanoicac
id methyl ester
Methyl iodide 2.8 Organic residue
Glacial acetic acid 150.0 To Wastewater
Ammonium 120 To Wastewater
chloride
Potassium 25 To Wastewater
Carbonate

Stage II
(Kg/day) (Kg/day)
Stage I Product 120.5 2-[2--[3(S)-[3-[2-(7- 100 Final Product
chloro-2-quinolinyl)
ethenyl]phenyl]-3-
hydroxypropyl]
phenyl]-2-propanol.
(-)-beta chlorodiisopino 84.8 Hydroxy MgCl 16.8 To Wastewater
camphenyl borane
Methyl magnesium chloride 40.1 Methoxy 19.8 To Wastewater
magnesium chloride
Methanol 8.5 (-)-beta 69.1 Organic Residue
Methoxydiisopinoca
mphenyl borane
Diethanolamine 80 Methanol Recovered 289.5 Recoverd & Reused
Cerium chloride 50 Methanol Loss 1.5 Fugitive Loss
Ammonium chloride (30%) 600 Methanol to water 3 To Wastewater
Toluene 1800 Methanol to Residue 6 Solvent in Residue
Hy-flow 50 Toluene Recovered 1746 Recoverd & Reused
Hexane 1000 Toluene Loss 7.2 Fugitive Loss
Water 4.76 Toluene to water 9 To Wastewater
Methanol 300 Toluene to Residue 37.8 Solvent in Residue
Water 3000 Hexane Recovered 970 Recoverd & Reused
Sodium Hydroxide 8.7 Hexane Loss 4 Fugitive Loss
Hexane to water 5 To Wastewater
Hexane to Residue 21 Solvent in Residue
(-)-beta 14.7 Organic Residue
chlorodiisopinocam
phenyl borane
Methyl magnesium 7 To Wastewater
chloride
Methanol 1.5 To Wastewater
Diethanolamine 80 To Wastewater
Cerium chloride 50 To Wastewater
Ammonium 180 To Wastewater
chloride
Hy-flow 50 Inorganic residue

2.1.20 Process Description of 2, 8-Diazo bicyclo Nonane

Reaction Schemes
Stage I
Stage II
Stage III

Stage IV
Stage-I: 2,3-Pyridine Dicarboxylic acid reacts with Acetic anhydride to form furo[3,4-
b]pyridine-5,7-dione and further reacts with Benzyl amine to form (3-
benzylcarbamoyl)picolinic acid (Stage-I compound).
Stage-II: (3-benzylcarbamoyl)picolinic acid is cyclization with 6-Benzyl-5H-pyrrol[3,4-

b]pyridine-5,7-(6H)dione and further undergoes reduction with Pd/C in presence of ethyl
acetate to form 6-Benzylhexahydro-5H-pyrrol[3,4-b]pyridine-5,7-(6H)dione (Stage-II
compound).
Stage -III: 6-Benzylhexahydro-5H-pyrrol[3,4-b]pyridine-5,7-(6H)dione undergoes reduction

to form 6-Benzyltetrahydro-5H-pyrrol[3,4-b]pyridine-5,7-(6H)dione and further reacts with
AlCl3 and SBH to form 6-Benzyloctahydro-1H-pyrrol[3,4-b]-pyridine (Stage-III compound).
Stage -IV: 6-Benzyloctahydro-1H-pyrrol [3, 4-b]-pyridine undergoes reduction with Pd/C

to form (s,s)-2,8-diazabicyclo[4.3.0]nonane (Stage-IV compound). The process flow diagram
(s,s)-2,8-diazabicyclo[4.3.0]nonane is presented in Fig 2.20.And material balance is presented
in Table 2.23.


Fig 2.20 Process Flow Diagram of 2, 8-Diazo bicyclo Nonane

Table 2.23 Material Balance for 2, 8-Diazo bicyclo Nonane

Stage I
(Kg/Day) (Kg/Day)
2,3-Pyridine 309.2 Stage I Product 376.1 To Stage-II
Dicarboxylicacid
Acetic anhydride 188.9 Acetic acid 176.3 To wastewater
Toluene 500 Methanol Recovered 720 Recovery & reuse
Benzylamine 198.1 Methanol Loss 1.5 Fugitive Loss
Methanol 750 Methanol to Residue 28.5 Solvent in Residue
Toluene Recovered 485 Recovery & reuse
Toluene Loss 1.3 Fugitive Loss
2,3-Pyridine 63.9 To Waste water
Dicarboxylicacid
Acetic anhydride 39 Organic residue
Benzylamine 40.9 Organic residue
Stage II
(Kg/Day) (Kg/Day)
Stage I Product 376.1 Stage II Product 382 To Stage-III
Ethyl acetate 2500 Ethyl acetate Recovered 2425 Recovery & reuse
Pd/C 15 Ethyl acetate Loss 7.5 Fugitive Loss
DM Water 3000 Ethyl acetate to water 20 To Wastewater
Tartaricacid 120 Ethyl acetate to Residue 47.5 Solvent in Residue
Methylene Dichloride 1200 MDC Recovered 1164 Recovery & reuse
Sodium carbonate 65 MDC Loss 3.6 Fugitive Loss
Hydrogen 9.5 MDC to Residue 32.4 Solvent in Residue
Tartaricacid 120 To Wastewater
Sodium carbonate 65 To Wastewater
DM Water 3000 To Wastewater
Hydrogen 0.1 Let Out into
atmosphere
Pd/C 15 To Spent carbon
Stage III
(Kg/Day) (Kg/Day)
Stage II Product 382 Stage III Product 327.9 To Stage-IV
Tetrahydrofuron(THF) 3000 Sodium Borohydride 217.6 To wastewater
Aluminium chloride 835.5 Aluminium chloride 809.6 Inorganic residue
Sodium Borohydride 236.4 THF Recovered 2910 Recovery & reuse
Water 3000 THF Loss 15 Fugitive Loss
Hydrochloric acid 35 THF to Residue 75 Solvent in Residue

Toluene 2500 Toluene Recovered 2400 Recovery & reuse

Sodium hydroxide 38.4 Toluene Loss 15 Fugitive Loss
Toluene to Residue 85 Solvent in Residue
Stage II Product 11.6 Organic residue
Aluminium chloride 25.4 Inorganic residue
Sodium Borohydride 7.2 To wastewater
Stage IV
(Kg/Day) (Kg/Day)
Stage III Product 327.9 (S,S)-2,8- 166.7 Final product
diazabicyclo[4.3.0] nonane
Methanol 2000.0 Toluene 121.7 Organic residue
Pd/C 20 Methanol Recovered 1950 Recovery & reuse
Hydrogen 3 Methanol Loss 15 Fugitive Loss
Stage III Product 42.1 Organic residue
Pd/C 20 Ogranic residue
Hydrogen 0.4 Let Out into
Atmosphere

2.1.21 Process Description of 2, 3, 4, 5-Bis-O- (1- methylethylidene)-b-D-fructopyranose

Reaction Schemes
Stage I
Stage -I: D-(-)-Fructose is reacted with acetone in presence of sulfuric acid in n-Hexane and
toluene to yield 2,3,4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose (Topiramate
Intermediate). The process flow diagram for 2, 3, 4, and 5-Bis-O-(1-methylethylidene)-beta-
D-fructopyranose (Topiramate Intermediate) is presented in Fig 2.21.Material balance is
presented in Table 2.24.
Fig 2.21 Process Flow Diagram of 2, 3, 4, 5-Bis-O- (1- methylethylidene)-b-D-

fructopyranose

Table 2.24 Material Balance for 2, 3, 4, 5-Bis-O- (1- methylethylidene)-b-D-fructopyranose

(Kg/day) (Kg/day)
D-(-)-Fructose 646 2,3,4,5-Bis-O-(1- 833.3 Final Product
methylethylidene)-beta-D-
fructopyranose (Topirama
Intermediate)
Sulfuric acid 150 Acetone Recovered 760 Recovery & reuse
Sodium hydroxide 122.4 Acetone Loss 6.4 Fugitive Loss
Acetone 416.3 Acetone to wastewater 6.6 To Wastewater
n-Hexane 1000 Acetone to Residue 27 Solvent in Residue
Toluene 3000 n-Hexane Recovered 950 Recovery & reuse
Isopropanol (IPA) 150 n-Hexane Loss 8 Fugitive Loss
Water 6000 n-Hexane to Residue 42 Solvent in Residue
Acetone 800 Toluene Recovered 2850 Recovery & reuse
Toluene Loss 24 Fugitive Loss
Toluene to wastewater 12.9 To Wastewater
IPA Recovered 142.5 Recovery & reuse
IPA Loss 1.2 Fugitive Loss
IPA to wastewater 1.4 To Wastewater
D-(-)-Fructose 69.1 To Wastewater
Acetone 45 To Wastewater
Sodium sulfate 217.3 To Wastewater

2.1.22 Process Description of 2- Acetyl Ethoxy acetyl methoxy ether

Reaction Schemes
Process Description
Stage-I: Acetic anhydride reacted with 1, 3 Dioxolane in presence of Sodium acetate and
sulfuric acid to gives (2-Acetoxyethoxy) methyl acetate.Process flow diagram is presented in
Fig 2.22.Material balance is presented in Table 2.25.
Fig 2.22 Process Flow Diagram of 2- Acetyl Ethoxy acetyl methoxy ether
Table 2.25 Material Balance for 2- Acetyl Ethoxy acetyl methoxy ether
(Kg/day) (Kg/day)
Acetic anhydride 896.5 (2-Acetoxyethoxy)methyl 1133 Final Product
acetate
1,3-Dioxolane 651.1 Acetic anhydride 240.3 Organic Residue
Sodium acetate 3.0 1,3-Dioxolane 174 Organic residue
Sulfuric acid 2.0 Sodium acetate 3 To Wastewater
Sodium Hydroxide 1.6 Sodium sulfate 2.9 To Wastewater
Water 80 Water 80.7 To Wastewater

2.1.23 Process Description of 1, 1-Carbonyl di imidazole

Reaction Schemes
Process Description
Stage-I: Imidazole Reacted with triphosgene in presence of Tributylamine in toluene to
gives 1, 1’-carbonyldiimidazole. Process flow diagram is presented in Fig 2.23.Material
Balance is presented in Table 2.26.
Fig 2.23 Process Flow Diagram of 1, 1-Carbonyl di imidazole
Table 2.26 Materila Balance of 1, 1-Carbonyl di imidazole

(Kg/day) (Kg/day)
1H Imidazole 2043.1 1,1-Carbonyl 1666.7 Final Product
diimidazole
bis(trichloromethyl) 4452 Trichloromethanol 2782.5 By-Product
carbonate
Tri butyl amine 3200 Toluene Recovered 8288 Recovery & reuse
Toluene 8500 Toluene Loss 43 Fugitive Loss
1H Imidazole 257.4 Organic Residue
386.2 Recovered & Reused
bis(trichloromethyl) 701.2 Organic Residue
carbonate 701.2 Recovered & Reused
Tri butyl amine 1280 Organic Residue
1920 Recovered & Reused

2.1.24 Process Description of (2S, 3S, 5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl

Amino 1, 6-diohenyl
Reaction Schemes
Stage I
Stage II
Stage III

Stage-I: Phenyl alanine and Benzyl chloride is reacted with acetonitrile and benzyl
magnesium chloride in presence of sodium amide and then treated with water in
tetrahydrofuran to yield Dibenzylamino diphenyl hexene (Stage-I compound).
Stage-II: Dibenzylamino diphenyl hexene is reacted with sodium borohydride in presence

of Methanol and then treated with Boc anhydride to yield Hydroxy butyloxy
carbonylamino diphenyl hexane (Stage II Compound).
Stage-III: Hydroxy butyloxy carbonylamino diphenyl hexane is deprotected with

Palladium carbon in presence of Methanol to yield Aminohydroxy butyloxy
diphenylhexane. The process flow diagram for Aminohydroxy butyloxy diphenyl hexane is
presented in Fig 2.24.and material balance is presented in Table 2.27.

Fig 2.24 Process Flow Diagram of (2S, 3S, 5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl

Amino 1, 6-diohenyl

Table 2.27 Material Balance for (2S, 3S, 5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl

Amino 1, 6-diohenyl
Stage I
(Kg/day) (Kg/day)
Phenyl alanine 62.4 Stage I Product 163.8 To Stage-II
Benzyl chloride 95.7 Magnesium Hydroxide 20.6 To Waste water
Benzyl magnesium 56.9 Sodium Chloride 62.4 To Wastewater
chloride
Sodium amide 14.7 Ammonium Hydroxide 12.4 To waste water
Caustic Lye (40%) 71.1 THF Recovered 945 Recovery & reuse
Acetonitrile 15.9 THF Loss 10 Fugitive Loss
Tetrahydrofuran (THF) 1000 THF to Wastewater 13 To wastewater
Activated carbon 10 THF to Residue 32 Solvent in Residue
Water 1113.6 Phenyl alanine 3.7 Organic residue
Benzyl chloride 5.7 Organic residue
Benzyl magnesium 3.4 Organic residue
chloride
Acetonitrile 1 To wastewater
Sodium amide 0.9 To wastewater
Stage II
(Kg/day) (Kg/day)
Sodium borohydride 13.5 Tert-Butyl alcohol 21.5 To Waste water
Boc anhydride 77.6 Sodium trymethoxy 37.2 Organic residue
borohydride
Methanol 34.2 Carbon Dioxide 12.8 Let out into
atmosphere
Water 650 Hydrogen 0.6 Let into atmosphere
through water
column
Activated carbon 8 Methanol Recovered 479.5 Recovery & reuse
Methanol 500 Methanol Loss 2 Fugitive Loss
Methanol to Wastewater 6.5 To wastewater
Boc anhydride 14.3 Organic residue
Methanol 6.3 To Waste water
Sodium borohydride 2.5 To Waste water
Water 650 To Waste water

Stage III
(Kg/day) (Kg/day)
Stage II Product 163.9 Aminohydroxy butyloxy 100 Final Product
diphenylhexane
Hydrogen 1.2 Toluene 47.9 To wastewater
Palladium carbon 20 Methanol Recovered 1455 Recovery & reuse
Activated carbon 10 Methanol to Wastewater 9 To wastewater
Water 1500 Methanol to Residue 30 Solvent in Residue
Stage II Product 17 Organic residue
Hydrogen 0.1 Let into atmosphere
through water
column
Palladium carbon 20 To spent catalyst

2.1.25 Process Description of Trans-4-(4-chlorophenyl)-cyclohexane carboxylic acid

Reaction Schemes
Stage I
Stage II
Stage-I: Tetra hydrobenzene is reacted with monochlorobenzene and Acetyl chloride in

presence of Con.HCl, AlCl3 and Toluene to give Trans-1-[4-(4-chlorophenyl)-cyclohexyl]-
ethanone (Stage-I compound).
Stage-II: Trans-1-[4-(4-chlorophenyl)-cyclohexyl]-ethanone is reacted with Sodium

hypochlorite and water in presence of NaOH, Sodium bisulphite and Ethanol to give Trans-
4-(4-chlorophenyl) cyclohexane carboxylic acid (Stage-II compound). The process flow
diagram for Trans-4-(4-chlorophenyl) cyclohexane carboxylic acid is presented in Fig 2.25.
And material balance is presented in Table 2.28.

Fig 2.25 Process Flow Diagram of Trans-4-(4-chlorophenyl)-cyclohexane carboxylic acid

Table 2.28 Material Balance for Trans-4-(4-chlorophenyl)-cyclohexane carboxylic acid

Stage I
(Kg/day) (Kg/day)
Tetrahydrobenzene 41 Stage I Product 105.3 To Stage II
Monochlorobenzene 56.2 Toluene Recovered 386 Recoverd & Reused
Aluminium Trichloride 15 Toluene Loss 2 Fugitive Loss
Acetyl chloride 39.2 Toluene to Wastewater 4 To Wastewater
Crushed ice 500 Toluene to Residue 8 Solvent in Residue
Toluene 400 Ethanol Recovered 241.3 Recoverd & Reused
10 % NaCl solution 20 Ethanol Loss 1.3 Fugitive Loss
Sodium Hydroxide 17.8 Ethanol to Wastewater 2.5 To Wastewater
Ethanol 250 Ethanol to Residue 5 Solvent in Residue
Monochlorobenzene 500 MCB Recovered 482.5 Recoverd & Reused
(MCB)
MCB Loss 2.5 Fugitive Loss
MCB to Wastewater 5 To Wastewater
MCB to Residue 10 Solvent in Residue
Tetrahydrobenzene 4.5 Organic residue
Monochlorobenzene 6.1 Organic residue
Acetyl chloride 4.3 Organic residue
Aluminium Trichloride 15 To Wastewater
Stage II
(Kg/day) (Kg/day)
Stage I Product 105.3 Trans-4-(4- 100 Final Product
chlorophenyl)cyclo
hexane carboxylic acid
Ethanol 1000 Carbon Monoxide 11.7 Let into Atmosphere
Sodium Hydroxide 12 Ethanol Recovered 965 Recoverd & Reused
Sodium hypo chlorite 99.5 Ethanol Loss 5 Fugitive Loss
Sodium Sulphite 15 Ethanol to Wastewater 10 To Wastewater
Hexane 200 Ethanol to Residue 20 Solvent in Residue
Con. Hydro chloric acid 11 Toluene Recovered 97 Recoverd & Reused
Toluene 100 Toluene Loss 0.4 Fugitive Loss
Water 2024 Toluene to Wastewater 0.5 To Wastewater
Hexane Recovered 194 Recoverd & Reused
Hexane Loss 0.8 Fugitive Loss
Hexane to Wastewater 1 To Wastewater
Hexane to Residue 4.2 Solvent in Residue

Sodium hypo chlorite 5.8 To Wastewater

Sodium sulphite 15 To Wastewater
Water 2014.3 To waste water
2.1.26 Process Description of Guanine

Reaction Schemes
Stage-I: 2,5,6-Triamino-3H-pyrimidin-4-one reacted with sulphuric acid & formic acid in
presence of water and sodium formate to give guanine.Process flow diagram is presented in
Fig 2.26. Material balance is presented in Table 2.29.
Fig 2.26 Process Flow Diagram of Guanine
Table 2.29 Material Balance for Guanine

(Kg/day) (Kg/day)
2,5,6-Triamino-3H- 2299 Guanine 1666.7 Final Product
pyrimidin-4-one
Sulfuric Acid 1598 Water 1384.3 To wastewater
Formic Acid 750 2,5,6-Triamino-3H- 742.5 Organic Residue
pyrimidin-4-one
Sodium Formate 1520 Formic Acid 242 To Wastewater
Water 400 Sodium Formate 456 Organic residue
Sodium Hydroxide 1304 1064 Recovered & reused
Sodium sulfate 2199.4 Inorganic residue
115.8 To Wastewater

2.1.27 Process Description of Poly allyl amine HCl

Reaction Schemes
Stage-I: Polyallyl amine is reacted with hydrochloric acid in presence of water and 2, 2’-
Azobis-(2-methylpropanamide) to yield Polyallylamine Hydrochloride.Process flow
Fig 2.27 Process Flow Diagram of Poly allyl amine HCl
Table 2.30 Material Balance for Poly allyl amine HCl

(Kg/day) (Kg/day)
Polyallylamine 355 Polyallylamine HCl 500 Final Product
Hydrochloric acid 227 Polyallylamine 50.4 Organic Residue
Water 3200 2,2’-Azobis-(2-methyl 4.1 To Wastewater
propanamide)
2,2’-Azobis-(2-methyl 4 Sodium chloride 51.8 To Wastewater
propanamide)
Sodium Hydroxide 35 Water 3215.9 To Wastewater

2.1.28 Process Description of Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4-flurophenyl)-6-isopropyl-2-

(N- methylmethane sulfonamido)Pyrimidin - 5-yl)vinyl)-2,2-dimethyl-1,3-dioxane-4-yl-)
acetate
Reaction Schemes
Stage I
Stage II
Stage III

Stage-I:Tert-Butyl-2 ((4R,6S)-6- (acetyloxy) methyl-2,2-dimethyl-1,3-dioxan-4-yl)acetate
reacts with water to form Tert-Butyl-2((4R,6S)-6-(hydroxymethyl)-2,2-dimethyl1,3-dioxan-4-
yl)acetate. (Stage-I compound).
Stage-II: Tert-Butyl-2((4R, 6S)-6-(hydroxymethyl)-2, 2-dimethyl-1,3-dioxan-4-yl)acetate

reacts with Sodium hypochlorite to form Tert-Butyl-2((4R,6S)-6-formyl-2,2-dimethyl-1,3-
dioxan-4-yl)acetate. (Stage II compound).
Stage-III: Tert-Butyl-2((4R,6S)-6-formyl-2,2-dimethyl-1,3-dioxan-4-yl)acetate is condense

with[[4-(4-Fluorophenyl)-6-(1-methylethyl)2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]
methyl] triphenylphoshonium bromide to form tert-butyl-2-((4R,6S)-6-((E)-2-(4-(4-
fluorophenyl)-6-isopropyl-2-(n-methylmethanesulfonamido)pyrimidin-5-yl)vinyl)-2,2-di
methyl - 1,3-dioxane-4-yl)acetate. (Stage-III compound).Process flow diagram is presented
in Fig 2.28.Material balance is presented in Table 2.31.

Fig 2.28 Process Flow Diagram of Tert-butyl 2-((4R, 6S)-6-((E)-2-(4-(4-flurophenyl)-6-

isopropyl-2-(N- methylmethane sulfonamido) Pyrimidin - 5-yl)vinyl)-2,2-dimethyl-1,3-

Table 2.31 Material Balance for Tert-butyl 2-((4R, 6S)-6-((E)-2-(4-(4-flurophenyl)-6-

isopropyl-2-(N- methylmethane sulfonamido) Pyrimidin - 5-yl)vinyl)-2,2-dimethyl-1,3-
Stage I
(Kg/day) (Kg/day)
Tert-Butyl-2((4R,6S)-6- 145.6 Stage I Product 124.1 To Stage-II
(acetyloxy)methyl-2,2-
dimethyl-1,3-dioxan-4-yl)
acetate
Methanol 350 Acetic acid 28.6 To wastewater
Potassium carbonate 30 Methanol Recovered 336 Recovery & reuse
Water 8.7 Methanol Loss 0.7 Fugitive Loss
Methylene dichloride 750 Methanol to Wastewater 3.5 To wastewater
(MDC)
Water 1500 Methanol to Residue 9.8 Solvent in Residue
MDC Recovered 720 Recovery & reuse
MDC Loss 1.5 Fugitive Loss
MDC to Wastewater 7.5 To wastewater
MDC to Residue 21 Solvent in Residue
Tert-Butyl-2((4R,6S)-6- 1.5 Organic residue
(acetyloxy)methyl-2,2-
dimethyl-1,3-dioxan-4-
yl)acetate
Potassium carbonate 30 To wastewater
Stage II
(Kg/day) (Kg/day)
Sodium hypochlorite 35.4 MDC Recovered 960 Recovery & reuse
Sodium bicarbonate 30 MDC Loss 2 Fugitive Loss
Water 1800 MDC to Wastewater 10 To wastewater
Potassium bromide 5 MDC to Residue 28 Solvent in Residue
Methylene dichloride 1000 Stage I Product 3.72 Organic residue
(MDC)
Sodium thiosulphate 30 Sodium hypochlorite 1.1 To wastewater
Sodium chloride 25 Sodium bicarbonate 30 To wastewater
Potassium bromide 5 Inorganic residue
Sodium thiosulphate 30 To wastewater
Stage III


(Kg/day) (Kg/day)
Stage II Product 119.3 Tert-Butyl-2-((4R,6S)-6-€- 166.7 Final Product
2-(4-(4-fluorophenyl)-6-
isopropyl-2-(N-
methylmethanesulfonam
ido) pyrimidin-5-yl)
vinyl)-2,2-dimethyl-1,3-
dioxane-4-yl) acetate
[[4-(4-Fluorophenyl)-6-(1- 313.4 Triphenyl Phosphene 80.3 To wastewater
methylethyl)2-[methyl oxide
(methylsulfonyl) amino]-
5-pyrimidinyl]methyl]
triphenyl phoshonium
bromide
Dimethyl sulfoxide 850 Bromine 23.4 To Scrubber
(DMSO)
Potassium carbonate 50 Methanol Recovered 768 Recovery & reuse
Toluene 1800 Methanol Loss 1.6 Fugitive Loss
Water 1500 Methanol to Wastewater 8 To wastewater
Methanol 800 Methanol to Residue 22.4 Solvent in Residue
DIP 700 Toluene Recovered 1728 Recovery & reuse
Hexane 600 Toluene Loss 3.6 Fugitive Loss
Toluene to Wastewater 18 To wastewater
DIP Recovered 672 Recovery & reuse
DIP Loss 1.4 Fugitive Loss
DIP to Wastewater 7 To wastewater
DIP to Residue 19.6 Solvent in Residue
Hexane Recovered 576 Recovery & reuse
Hexane Loss 1.2 Fugitive Loss
Hexane to Wastewater 6 To wastewater
Hexane to Residue 16.8 Solvent in Residue
DMSO Recovered 816 Recovery & reuse
DMSO Loss 1.7 Fugitive Loss
DMSO to Wastewater 8.5 To wastewater
DMSO to Residue 23.8 Solvent in Residue
Potassium carbonate 50 To wastewater

2.1.29 Process Description of 5-Cyano phthalide

Reaction Schemes
Stage I
Stage II
Stage III
Stage-I: 5-Carboxy phthalide reacts with thionyl chloride and ammonia Gas to get 5-
Phthalide carboxamide.
Stage-II: 5-Phthalide carboxamide reacts with Thynoyal chloride to get 5-cyano phthalide
(crude).

Stage-III: 5-cyano phthalide (crude) undergoes purification with Dimethyl formamaide and
Methanol to get 5-cyano phthalide.Process flow diagram is presented in Fig 2.29.And
material balance is presented in Table 2.32.

Fig 2.29 Process Flow Diagram of 5-Cyano phthalide

Table 2.32 Material Balance for 5-Cyano phthalide

Stage I
(Kg/Day) (Kg/Day)
5-Carboxy Phthalide 1636.4 Stage I Product 1514.6 To Stage-II
Thionyl Chloride 1017.4 Sulfur Dioxide 547.3 To Scrubber
Toluene 2800 Hydrogen chloride 624.3 To Scrubber
Di Methyl Formamide 20 Toluene Recovered 2688 Recovery & reuse
Ammonia Gas 156.2 Toluene Loss 5.6 Fugitive Loss
Water 2300 Toluene to Wastewater 28 To wastewater
5-Carboxy Phthalide 112.9 Organic residue
Di Methyl Formamide 20.0 To wastewater
Ammonia Gas 10.8 To Scrubber
Total Input 7930 Total Output 7930
Stage II
(Kg/Day) (Kg/Day)
Thionyl chloride 816.7 Sulfur Dioxide 439.2 To Scrubber
Ethylene Dichloride (EDC) 3500 Hydrogen Chloride 501.0 To Scrubber
Di Methyl Formamide 25 Methanol Recovered 960 Recovery & reuse
Methanol to Wastewater 0.0 To wastewater
EDC Recovered 3360 Recovery & reuse
EDC Loss 7 Fugitive Loss
EDC to Wastewater 0.0 To wastewater
EDC to Residue 133 Solvent in Residue
Di Methyl Formamide 25 Organic residue
Stage III
(Kg/Day) (Kg/Day)
Stage II Product 1091.2 5 Cyano Phthalide 666.7 Final Product
Dimethylformamide 2500.0 Methanol Recovered 192 Recovery & reuse
Hyflow 8 Methanol Loss 0.4 Fugitive Loss
Methanol 200 Methanol to Wastewater 0.0 To wastewater
DMF Recovered 2400 Recovery & reuse
DMF Loss 5 Fugitive Loss
DMF to Wastewater 0.0 To wastewater
DMF to Residue 95 Solvent in Residue
Hyflow 8 Inorganic residue

2.1.30 Process Description of 1, 1-Cyclohexanediacetic acid

Reaction Schemes
Stage I
Stage-I:
Cyclohexanone reacted with methyl cyanoacetate and ammonia gas in presence of Toluene
to gives 1, 1-cyclohexyl dicyano amide and this under goes to hydrolysis with water to
gives 1, 1-Cyclohexanediacetic acid.Process flow diagram is presented in Fig 2.30.Material
balance can be presented in Table 2.33.
Fig 2.30 Process Flow Diagram of 1, 1-Cyclohexanediacetic acid

Table 2.33 Material Balance for 1, 1-Cyclohexanediacetic acid

(Kg/Day) (Kg/Day)
Cyclohexanone 989.1 1,1-cyclohexane di 1666.7 Product
aceticacid
2-methyl cyano acetate 1995.9 Ammonia gas 566.7 To Scrubber
Ammonia gas 325.6 Carbon dioxide 733.3 Let into Atmosphere
Toluene 3000 Methanol 266.7 To wastewater
Water 5588.7 266.7 Recovered & resued
Sulfuric Acid 50 IPA Recovered 4850 Recovery & reuse
Isopropanol (IPA) 5000 IPA Loss 12.5 Fugitive Loss
Sodium Hydroxide 40.8 IPA to Wastewater 35.5 To wastewater
Toluene Recovered 2910 Recovery & reuse
Toluene Loss 7.5 Fugitive Loss
Toluene to 12.3 To wastewater
Wastewater
Cyclohexanone 171.4 Organic residue
2-methyl cyano 345.9 Organic residue
acetate
Ammonia gas 42.3 To Scrubber
Sodium sulfate 72.7 To Waste water

2.1.31 Process Description of Carbamyl Methyl-5-Methyl hexanoic Acid

Reaction Schemes
Stage-I: Isovaleraldehyde reacted with Cyanoacetamide, water and urea in presence of
hydrochloric acid to gives 3-(Carbamoylmethyl)-5-methylhexanoic acid.Process flow
Fig 2.31 Process Flow Diagram of Carbamyl Methyl-5-Methyl hexanoic Acid

Table 2.34 Material Balance for Carbamyl Methyl-5-Methyl hexanoic Acid

(Kg/Day) (Kg/Day)
Isovalaraldehyde 285.5 3-Carbomylmethyl-5- 500 Final Product
methylhexanoic acid
2-Cyanoacetamide 557.4 Ammonia gas 227.3 To Scrubber
Water 477.3 Carbon dioxide 352.5 Let into
Atmosphere
Urea 199 Toluene Recovered 2425 Recovery & reuse
Hydrochloric acid (33%) 100 Toluene Loss 2.5 Fugitive Loss
Toluene 2500 Toluene to Wastewater 10.3 To wastewater
Ethylacetate 1200 Toluene to Residue 62.3 Solvent in Residue
Piperidine 12 Ethylacetate Recovered 1164 Recovery & reuse
Sodium Hydroxide 36.2Ethylacetate Loss 3 Fugitive Loss
Ethylacetate to water 12 To wastewater
Ethylacetate to Residue 21 Solvent in Residue
Isovalaraldehyde 55.5 Organic Residue
2-Cyanoacetamide 108.36 Organic Residue
Urea 38.7 Organic Residue
Sodium Chloride 53 To wastewater
Piperidine 12 Inorganic residue

2.1.32 Process Description of 2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine

Reaction Schemes
Stage I
Stage II
Stage-I: Methyl-2,3-O-isopropylidene-5-deoxy-D-ribofuranoside reacts with Acetic
anhydride in presence of DM water, sulphuric acid, sodium carbonate, triethyl amine,
methylene chloride, hydrochloric acid and sodium sulphate to form 1,2,3-Tri-o-acetyl-5-
deoxy-beta-D-ribofuranose.
Stage-II: 1,2,3-Tri-o-acetyl-5-deoxy-beta-D-ribofuranose condensed with 5-Fluorocytidine in

presence of Toluene, hexamethyldisilazane, trimethyl chlorosilane, methylene chloride,
stannic chloride, sodium bicarbonate, water, sodium bicarbonate and isopropyl alcohol to
form 2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine.Process flow diagram is presented in Fig
2.32.Material balance is presented in Table 2.35.

Stage I
Stage II
Fig 2.32 Process Flow Diagram of 2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine

Table 2.35 Material Balance for 2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine

Stage I
(Kg/Day) (Kg/Day)
Methyl-2,3-O- 105.1 Stage I Product 130.8 To Stage-II
isopropylidene-5-deoxy-
D-ribofuranoside
Acetic anhydride 114 Methanol 16.1 To wastewater
DM Water 650.2 propane-2,2-diol 38.2 To wastewater
Tri ethylamine (TEA) 200 Acetic acid 30.2 To wastewater
Methylene Dichloride 600 TEA Recovered 194 Recovery & reuse
(MDC)
Di isopropyl ether (DiPE) 400 TEA Loss 0.5 Fugitive Loss
Sulfuric acid 10 TEA to Wastewater 2 To wastewater
Sodium carbonate 5 TEA to Residue 3.5 Solvent in Residue
Hyflow 5 MDC Recovered 582 Recovery & reuse
Activated carbon 10 MDC Loss 2.1 Fugitive Loss
Sodium Hydroxide 8.2 MDC to Wastewater 1.9 To wastewater
MDC to Residue 14 Solvent in Residue
DiPE Recovered 388 Recovery & reuse
DiPE Loss 1.4 Fugitive Loss
DiPE to Wastewater 4.0 To wastewater
Stage III Product 10.5 Organic residue
Acetic anhydride 11.4 Organic residue
Sodium sulfate 14.5 To wastewater
Sodium carbonate 5 To wastewater
Hyflow 5 inorganic residue
2107.4 Total Output 2107.5
Stage II
(Kg/Day) (Kg/Day)
Stage I Product 130.8 2',3'-Di-O-acetyl-5'- 133.3 Final Product
deoxy-5-fluorocytidine
5-Fluorocytosine 64.9 Acetic acid 24.3 To wastewater
Toluene 500 Toluene Recovered 475 Recovery & reuse
Dichloro methane (DCM) 850 Toluene Loss 10 Fugitive Loss
Isopropyl alcohol (IPA) 400 Toluene to Wastewater 5 To wastewater
Hexa methyl disilazane 25 Toluene to Residue 10 Solvent in Residue
Tri methyl chlorosilane 12 DCM Recovered 824.5 Recovery & reuse
Stannic chloride 35 DCM Loss 2.1 Fugitive Loss
Sodium bi carbonate 25 DCM to Wastewater 8.5 To wastewater
Sodium carbonate 8 DCM to Residue 14.9 Solvent in Residue
Water 600 IPA Recovered 380 Recovery & reuse

IPA Loss 8 Fugitive Loss

IPA to Wastewater 4 To wastewater
Stage IV Product 25.4 Organic Residue
5-Fluorocytosine 12.6 Organic Residue
Hexa methyl disilazane 25 Organic Residue
Tri methyl chlorosilane 12 Organic Residue
Stannic chloride 35 To wastewater
Sodium bicarbonate 25 To wastewater
Sodium sulphate 8 Inorganic residue

2.1.33 Process Description of N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine

amine
Reaction Schemes
Stage I
Stage II
Stage-I: (2-Methyl-5-nitrophenyl) guanidine react with (E)-3-(dimethylamino)-1-(pyridin-3-
yl)prop-2-en-1-one in presence of sodium hydroxide in isopropyl alcohol to give 1,3-
benzenediamine, 4-methyl-N3-[4-(3-pyridinyl)]-2-pyrimidinyl. (Stage -II compound).
Stage-II: 1, 3-benzenediamine, 4-methyl-N3-[4-(3-pyridinyl)]-2-pyrimidinyl react with raney

Ni in presence of methanol to give N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine
amine. Process flow diagram is represented in Fig 2.33.Material balance is presented in
Table 2.36.

Fig 2.33 Process Flow Diagram of N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-

pyrimidine amine

Table 2.36 Material Balance for N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine

amine
Stage I
(Kg/Day) (Kg/Day)
(2-Methyl-5- 370.2 Stage I Product 568.5 To Stage-II
nitrophenyl)guanidine.
(E)-3-(dimethylamino)-1- 336.1 Dimethyl amine 83.3 Organic residue
(pyridin-3-yl)prop-2-en-1-
one
Sodium hydroxide 80 n-butanol Recovered 2425 Recovery & reuse
n-butanol 2500 n-butanol Loss 6.3 Fugitive Loss
Isopropanol (IPA) 2000 n-butanol to water 20.3 To wastewater
methanol 2000 n-butanol to Residue 48.5 Solvent in Residue
water 2800 IPA Recovered 1940 Recovery & reuse
Hydrochloric acid 73 IPA Loss 7 Fugitive Loss
IPA to Wastewater 14.2 To wastewater
Methanol Recovered 1940 Recovery & reuse
Methanol Loss 7 Fugitive Loss
Methanol to water 20 To wastewater
Sodium chloride 116.9 To Waste water
10159.2 Total Output 10159.2
Stage II
(Kg/Day) (Kg/Day)
Stage I Product 568.5 N-(2-Methyl-5- 333.3 Final Product
aminophenyl)-4-(3-
pyridyl)-2-pyrimidine
amine
Hydrogen gas 11.1 Methanol Recovered 2425 Recovery & reuse
Methanol 2500 Methanol Loss 6.3 Fugitive Loss
Rany nickel 50 Methanol to water 25 To wastewater
Water 600 Methanol to Residue 43.8 Solvent in Residue
Hydrogen gas 3.9 Let Into
atmosphere
through water
column
Rany nickel 50 Residue

2.1.34 Process Description of 4-[(4-Methylpiperazin-1-yl) methyl] benzoic acid diHCl

Reaction Schemes
Stage I
Stage-I: 4-Cyanobenzyl bromide reacts with N-methyl piperazine in presence of Triethyl
amine and Toluene, Further this is reacts with HCl to give Benzoic acid, 4-[(4-methyl-1-
piperazinyl) methyl] dihydrochloride.Process flow diagram can be presented in Fig
2.34.Material balance is presented in Table 2.37.
Fig 2.34 Process Flow Diagram of 4-[(4-Methylpiperazin-1-yl) methyl] benzoic acid diHCl

Table 2.37 Material Balance for 4-[(4-Methylpiperazin-1-yl) methyl] benzoic acid diHCl
(Kg/Day) (Kg/Day)
4-Cyanobenzyl 297.5 Benzoic acid, 4-[(4- 333.3 Final Product
bromide methyl-1-piperazinyl)
methyl] dihydrochloride
N-Methyl piperazine 151.9 Hydrogen Bromide 87.8 To scrubber
Triethyl amine (TEA) 150 Ammonium gas 18.5 To scrubber
Toluene 1800 TEA Recovered 145.5 Recovery & reuse
Con.HCl 31.6 TEA Loss 0.4 Fugitive Loss
DM Water 2100 TEA to Wastewater 1.5 To wastewater
Sodium Hydroxide 34.6 TEA to Residue 2.6 Solvent in Residue
Water 54.6 Toluene Recovered 1746.0 Recovery & reuse
Hydrochloric acid 110.8 Toluene Loss 4.5 Fugitive Loss
Toluene to Wastewater 18 To wastewater
4-Cyanobenzyl bromide 84.78 Organic residue
N-Methyl piperazine 43.29 Organic residue
DM Water 2131.6 To wastewater

2.1.35 Process Description of 2, 3-Epoxy-2-methyl-N-[4-cyano-3-(trifluoromethyl)

phenyl] propanamide
Reaction Schemes
Stage I
Stage II
Stage III
Stage-I: 2-Methylacrylic acid reacts with Thionyl chloride in presence of
Dimethylformamide to form 2-Methylacrylolyl chloride (Stage-I compound).
Stage-II: 2-Methylacrylolyl chloride is condense with 4-Amino-2-
(trifluoromethyl)benzonitrile in presence of N,N-dimethyl acetamide, Water, Toluene and
4-Dimethylamino pyridine to form N-[4-Cyano-3-(trifluoromethyl)phenyl]meth-acrylamide.
(Stage II compound).
Stage-III: N-[4-Cyano-3-(trifluoromethyl)phenyl]meth-acrylamide reacts with m-Chloro
perbenzoic acid in presence of Chloroform, water, Toluene, Dimethylformamide,Sodium

Bicarbonate and Sodium sulphate to formcyano-3-(trifluoromethyl)phenyl] propanamide.

Process flow diagram is presented in Fig 2.35.Material balance is presented in Table 2.38.
Fig 2.35 Process Flow Diagram of 2, 3-Epoxy-2-methyl-N-[4-cyano-3-(trifluoromethyl)

phenyl] propanamide

Table 2.38 Material Balance for 2, 3-Epoxy-2-methyl-N-[4-cyano-3-(trifluoromethyl)

phenyl] propanamide
Stage I
(Kg/Day) (Kg/Day)
2-Methylacrylic acid 92.9 Stage I Product 101.6 To Stage-II
Thionyl chloride 115.7 Sulfur Dioxide 62.2 To Scrubber
Dimethylformamide 20 Hydrogen Chloride 35.5 To Scrubber
(DMF)
DMF Recovered 19.2 Recovery & reuse
DMF Loss 0.2 Fugitive Loss
DMF to Residue 0.6 Solvent in Residue
2-Methylacrylic acid 9.3 Organic residue
Stage II
(Kg/Day) (Kg/Day)
4-Amino-2- 180.9 Toluene Recovered 970 Recovery & reuse
(trifluoromethyl)
benzonitrile
N,N-Dimethyl 1500 Toluene Loss 2.5 Fugitive Loss
acetamide (DMA)
Toluene 1000 Toluene to water 10 To wastewater
4-Dimethylamino 5 Toluene to Residue 17.5 Solvent in Residue
pyridine
Water 5000 DMA Recovered 1455 Recovery & reuse
Sodium Hydroxide 35.0 DMA Loss 5.3 Fugitive Loss
DMA to water 15 To wastewater
DMA to Residue 24.8 Solvent in Residue
4-Amino-2- 18.1 Organic residue
(trifluoromethyl)
benzonitrile
4-Dimethylamino 5 Organic residue
pyridine
7822.5 Total Output 7822.5

Stage III
(Kg/Day) (Kg/Day)
Stage II Product 222.3 2,3-Epoxy-2-methyl-N- 166.7 Final Product
[4-cyano-3-
(trifluoromethyl)
phenyl] propanamide
m-chloroperbenzoic 151 m-chloro benzoic acid 96.6 To wastewater
acid
Chloroform 800 Chloroform Recovered 776 Recovery & reuse
Toluene 600 Chloroform Loss 2 Fugitive Loss
Dimethylformamide 300 Chloroform to water 8 To wastewater
(DMF)
Sodium bicarbonate 150 Chloroform to Residue 14 Solvent in Residue
Sodium sulphate 85 Toluene Recovered 570 Recovery & reuse
Water 2500 Toluene Loss 12 Fugitive Loss
Toluene to water 6 To wastewater
DMF Recovered 285 Recovery & reuse
DMF Loss 7.5 Fugitive Loss
DMF to Wastewater 3 To wastewater
DMF to Residue 4.5 Solvent in Residue
Stage II Product 65.5 Organic Residue
m-chloroperbenzoic acid 44.5 To wastewater
Sodium bicarbonate 150 To wastewater
Sodium sulphate 85 To wastewater

2.2 Utilities
The proposed expansion requires additional steam for both process and effluent treatment
system. It is proposed to establish coal fired boilers of capacity of 2 x 10 TPH in addition to
existing 2 TPH coal fired boiler. The DG sets required for emergency power during load
shut down is estimated at 2250 KVA and accordingly 2 x 1000 Kva DG sets are proposed for
expansion in addition to existing 1 x 250 Kva. The list of utilities is presented in Table 2.39.
Table 2.39 List of Utilities
S.No Utility Permitted Proposed After Expansion
1 Coal Fired Boilers (TPH) 1x2 2 x 10 2 x 10
1x2
2 Thermic Fluid Heater (K.Cal) 1 Lac --- 1 Lac
3 DG Sets (kVA)* 1 x 250 2 x 1000 2 x 1000
1 x 250
2.3 Water Requirement (Terms of Reference No. 3(vii))

Water is required for process, scrubbers, washing, cooling tower makeup, steam generation
and domestic purposes. The total water requirement after expansion increased from 13.76
KLD to 468.3 KLD out of which 298.27 KLD fresh water and 170 KLD of recycled water. The
required water shall be drawn from ground water in addition to reuse of treated
wastewater. The water balance for daily consumption after expansion is presented in Table
2.40.
Table 2.40 Total Water Balance – After Expansion
Purpose INPUT (KLD) OUTPUT (KLD)
Fresh Water Recycled Water Loss Effluent
Process 91.27 102.56*
Washings 10 10
Scrubber 10 10
Boiler 95 85 10
Cooling Tower 60 160 194 26
RO/DM Rejects 24 24
Domestic 10 1.5 8.5
Water for gardening 8 8
Gross Total 298.27 170 288.5 191.03
Total 468.3 479.56
* Process Effluents contains unreacted raw materials, soluble solvents, by-products etc.

2.4 Pollution Control Facilities:
Liquid Effluents, air emissions and solid wastes generated are the major pollutants from the
process operations of bulk drug manufacturing. The pollution control measures proposed to
treat/mitigate the emissions and effluents are described as follows.
2.4.1 Water Pollution:
The effluent generated from the proposed expansion of M/s. Cirex Pharmaceuticals Limited
is mainly from process, washings, scrubbers, cooling towers & boiler blow downs, RO/DM
rejects from pre-treatment of water and domestic effluent. It is proposed to treat all HTDS
effluent in stripper followed by MEE and ATFD. All LTDS effluent along with condensate
from MEE & ATFD shall be treated in Biological treatment followed by RO system. RO
Rejects sent to MEE and permeate is used for cooling towers as make up and scrubbers.
Total Effluent generated and mode of treatment before and after expansion is presented in
Table 2.41. Quantity and quality of effluents generated from process product wise is
presented in Table 2.42 and stage wsie is presented in Table 2.43.
Table 2.41 Total Effluent Generated and Mode of Treatment

Description Quantity (KLD) Mode of Treatment
Permitted After
Expansion
HTDS Effluents
Process 4.52 102.56 Sent to Stripper followed by MEE and ATFD.
Washings 1 10 Stripper Condensate sent to Cement Plants for Co-
Incineration. MEE and ATFD Condensate sent to
Biological treatment plant followed by RO. RO
rejects sent to MEE and permeate is reused in
cooling towers make-up and scrubbers.
Scrubber Effluent 10 Sent to MEE followed by AFTD, Biological
RO/DM Plant 24 treatment plant and RO.
Rejects
Total I 5.52 146.56
LTDS Effluents
Boiler Blow downs 1 10 Sent to Biological Treatment System followed by
Cooling Tower Blow 0.5 26 RO. RO permeate reused for cooling tower
downs makeup and scrubbers. RO rejects sent to MEE.
Domestic 1 8.5
Total II 2.5 44.5
Grand Total (I+II) 8.02 191.06

Table 2.42 Process Effluents - Quality and Quantity - Product Wise

S.No Name of Product Quantity (Kg/day) Concentration
(mg/l)
Water TDS COD Total TDS COD
Input Effluent
1 Amlodipine Besylate 3528.4 230 220.7 3894.1 59064 56675
2 Bupropion 3200 360 70.6 3601.1 99969 19617
3 Clopidogrel 3300 134.2 205.0 3707.5 36210 55288
4 Desvelofloxin 3000 9.6 148.5 3155.6 3040 47068
5 Divolproex Sodium 0 1.2 0 34.4 34121 0
6 Dulaxetine HCl 1100 46.8 52.4 1191 39258 43967
7 Esomeprazole MgTrihydrate 4833.5 241.3 146.7 5235.5 46081 28012
8 Glimepiride 1200 32.0 33 1260.1 25395 26167
9 Mesalamine 3600 312.3 65.7 4007.8 77931 16383
10 Metaprolol 3300 104.5 12.7 3441.3 30355 3679
11 Pantoprazole Na 3445 453.3 43.6 5055.7 89666 8634
12 Pragabalin 3578.7 307.6 228.9 4214.5 72980 54312
13 Rosuvastatin 1112.5 23.2 44.6 1158.9 19985 38497
14 Sertraline HCl 3500 111.3 338.7 3872 28754 87488
15 Tramadal 6053.6 454.5 200.7 6750.6 67329 29735
16 Valaciclovir 5555.1 253.1 491.3 6650.5 38064 73878
17 4-[4-Chloro-1-oxobutyl]-2, 2- 6500 528.0 55.2 7515.2 70264 7343
dimethyl phenyl acetic acid methyl
ester
18 N2-(1-(S)-ethoxy carbonyl-3- 2700 122.9 122.7 3065.1 40094 40030
phenyl propyl-N6-trifluoro acetyl-
L-lysine
19 2-[2--[3(S)-[3-[2-(7-chloro-2- 4304.8 466.3 315.7 5944.0 78447 53108
quinolinyl) ethenyl] phenyl]-3-
hydroxy propyl] phenyl]-2-
propanol.
20 2,8 -Diazo bicyclo Nonae 6000 345.8 131.5 6557.7 52727 20046
21 2,3,4,5-Bis-O- (1- methylethylidene) 6000 217.3 192.0 6522.4 33323 29442
-b-D-fructopyranose
22 2- Acetyl Ethoxy acetyl methoxy 80 5.9 1.1 86.6 68080 12702
ether
23 N,N-Carbonyl di imidazole 0 0 0 0 0 0
24 (2S,3S,5S)-2-Amino-3-Hydroxy-5- 3263.6 98.8 45.5 3440.8 28715 13233
Tert-Butylcarbonyl
Amino 1,6-diohenyl
25 Trans-4- (4-chlorophenyl)- 2524 177.6 39.1 2740.9 64790 14264
cyclohexane carboxylic acid
26 Guanine 400 115.8 168.5 1742.3 66440 96721
27 Poly allyl amine HCl 3200 51.8 5.1 3271.8 15825 1547
28 Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4- 4808.7 286.7 126.0 5184 55313 24307
flurophenyl)-6-isopropyl-2-(N-

methyl methane sulfonamido)

Pyrimidin - 5-yl)vinyl)-2,2-
dimethyl-1,3-dioxane -4-yl-)
acetate
29 5-Cyano Phthalide 2300 20.0 68.2 2348 8518 29035
30 1,1-Cyclohexane diacetic acid 5588.7 72.7 353.4 5244.2 13854 67393
31 Carbamyl Methyl-5- Methyl 777.3 52.9 42.4 695.4 76056 60987
hexanoic acid
32 2',3'-Di-O-acetyl-5'-deoxy-5- 1250.2 79.5 108 1411.2 56356 76550
fluorocytidine
33 N-(2-Methyl-5-aminophenyl)-4-(3- 3400 116.9 102.7 3708.9 31513 27688
pyridyl)-2- pyrimidine amine
34 4-[(4-Methyl piperazin-1-yl) 2154.6 50.5 46.7 2201.1 22948 21206
methyl] benzoic acid DiHCl
35 2, 3-Epoxy-2-methyl-N-[4-cyano-3- 7500 286.1 192.9 7940.5 36032 24296
(trifluoromethyl) phenyl]
propanamide
Total Worst Case: 20 Products on 91274.3 5521.1 4027.2 102556.5 53835 39268
Campaign basis

Table 2.41 Process Effluents - Quality and Quantity – Stage Wise

Amlodipine Besylate
1 Stage Quantity (Kg/Day) Concentration(mg/l)
Water Input TDS COD Total Effluent TDS COD
I 3528.4 230 220.7 3894.1 59064 56675
Total 3528.4 230 220.7 3894.1 59064 56675
Bupropion
I 3200 360 70.6 3601.1 99969 19617
II 0 0 0 0
Total 3200 360 70.6 3601.1 99969 19617
Clopidogrel
I 1800 37.8 141.8 2048.5 18436 69246
II 1500 96.5 63.1 1659 58156 38053
Total 3300 134.2 205 3707.5 36210 55288
Desvelofloxin
I 3000 9.6 148.5 3155.6 3040 47068
II
Total 3000 9.6 148.5 3155.6 3040 47068
Divolproex Sodium
I 0 0 0 0 0 0
II 0
III 1.2 34.4 34121 0
Total 0 1.2 0 34.4 34121 0
Dulaxetine HCl
I 1100 46.8 52.4 1191 39258 43967
Total 1100 46.8 52.4 1191 39258 43967
Esomeprazole MgTrihydrate
I 4833.5 241.3 146.7 5235.5 46081 28012
Total 4833.5 241.3 146.7 5235.5 46081 28012

Glimepiride
I 1200 32 33 1260.1 25395 26167
Total 1200 32 33 1260.1 25395 26167
Mesalamine
I 3600 312.3 65.7 4007.8 77931 16383
Total 3600 312.3 65.7 4007.8 77931 16383
Metaprolol
I 2000 104.5 2136.1 48902
II 1300 12.7 1305.2
III
Total 3300 104.5 12.7 3441.3 30355 3679
Pantoprazole Na
I 3445 453.3 43.6 5055.7 89666 8634
Total 3445 453.3 43.6 5055.7 89666 8634
12.Pragabalin
I 3578.7 307.6 228.9 4214.5 72980 54312
Total 3578.7 307.6 228.9 4214.5 72980 54312
Rosuvastatin
I 1112.5 23.2 44.6 1158.9 19985 38497
Total 1112.5 23.2 44.6 1158.9 19985 38497
Sertraline HCl
I 3500 111.3 338.7 3872 28754 87488
Total 3500 111.3 338.7 3872 28754 87488

Tramadal
I 6053.6 454.5 200.7 6750.6 67329 29735
Total 6053.6 454.5 200.7 6750.6 67329 29735
Valaciclovir
I 2528.8 219.2 222.7 3440.6 63696 64735
II 3026.3 34.0 268.6 3209.9 10590 83678
Total 5555.1 253.1 491.3 6650.5 38064 73878
4-[4-Chloro-1-oxobutyl]-2, 2- dimethyl phenyl acetic acid

methyl ester
I 2500 192.2 12.9 2805.1 68514 4604
II 1500 132.4 32.9 1760.5 75200 18697
III 2500 203.5 9.4 2949.6 68983 3170
Total 6500 528.0 55.2 7515.2 70264 7343
N2-(1-(S)-ethoxy carbonyl-3-phenyl propyl-N6-trifluoro acetyl-L-lysine

I 1200 32 104.3 1361.7 23500 76564
II 1500 90.9 18.4 1703.4 53358 10826
Total 2700 122.9 122.7 3065.1 40094 40030
2-[2--[3(S)-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-hydroxypropyl] phenyl]-2-
propanol.
I 1300 146.2 180.7 2100.6 69580 86039
II 3004.8 320.1 134.9 3843.3 83293 35110
Total 4304.8 466.3 315.7 5944 78447 53108
2,8 -Diazo bicyclo Nonae

I
II 3000 65.0 131.5 3205 20281 41015
III 3000 280.8 3352.7 83743 0
IV
Total 6000 345.8 131.5 6557.7 52727 20046

2,3,4,5-Bis-O- (1- methylethylidene)-b-D-fructopyranose

I 6000 217.3 192 6522.4 33323 29442
Total 6000 217.3 192 6522.4 33323 29442
2- Acetyl Ethoxy acetyl methoxy ether

I 80 5.9 86.6 68080 0
Total 80 5.9 0 86.6 68080 0
1,1 Carbonyl di imidazole

I
Total 0 0 0 0
(2S,3S,5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl Amino 1,6-diohenyl

I 1113.6 96.3 23.7 1266.5 76044 18745
II 650 2.5 12.8 665.3 3743 19227
III 1500 9 1509 0 5964
Total 3263.6 98.8 45.5 3440.8 28715 13233
Trans-4-(4-chlorophenyl)-cyclohexane carboxylic acid

I 500 43 21.7 580.6 74134 37440
II 2024 134.5 17.4 2160.4 62279 8036
Total 2524 177.6 39.1 2740.9 64790 14264
Guanine
I 400 115.8 168.5 1742.3 66440 96721
Total 400 115.8 168.5 1742.3 66440 96721
Poly allyl amine HCl
I 3200 51.8 5.1 3271.8 15825 1547
Total 3200 51.8 5.1 3271.8 15825 1547

Tert-butyl 2-((4R,6S) -6-((E)-2-(4-(4- flurophenyl)-6- isopropyl-2- (N- methylmethane

sulfonamido)Pyrimidin - 5-yl) vinyl)-2,2- dimethyl-1,3-dioxane-4-yl-) acetate
I 1508.7 30.0 36.9 1569.7 19112 23484
II 1800 126.4 3.8 1936.4 65287 1946
III 1500 130.3 85.4 1677.8 77670 50883
Total 4808.7 286.7 126.0 5184.0 55313 24307
5-Cyano Phthalide
I 2300 20.0 68.2 2348.0 8518 29035
II
III
Total 2300.0 20.0 68.2 2348.0 8518 29035
1,1-Cyclohexanediacetic acid
I 5588.7 72.7 353.4 5244.2 13854 67393
Total 5588.7 72.7 353.4 5244.2 13854 67393
Carbamyl Methyl-5-Methyl hexanoic acid

I 477.3 52.9 42.4 395.4 133760 107258
Total 477.3 52.9 42.4 395.4 133760 107258
2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine
I 650.2 19.5 60.3 709.4 27531 85029
II 600 60 47.7 701.8 85493 67979
Total 1250.2 79.5 108 1411.2 56356 76550
N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine amine
I 2800 116.9 77.7 3040.6 38439 25551
II 600 25 668.3 0 37410
Total 3400 116.9 102.7 3708.9 31513 27688
4-[(4-Methylpiperazin-1-yl)methyl]benzoic acid dihydrochloride
I 2154.6 50.5 46.7 2201.1 22948 21206
Total 2154.6 50.5 46.7 2201.1 22948 21206

2, 3-Epoxy-2-methyl-N-[4-cyano-3-(trifluoromethyl) phenyl] propanamide

I
II 5000 51.1 46.4 5091.9 10037 9110
III 2500 235.0 146.5 2848.6 82496 51441
Total 7500 286.1 192.9 7940.5 36032 24296
2.4.1.1 Process Description and Technical Specification of Effluent Treatment System
The Effluent management system is developed to ensure `Zero Liquid Discharge’.

Segregation of effluents is an integral part that facilitates effective treatment of various
effluent streams. The effluents are segregated into two streams; High COD/ TDS and Low
COD/ TDS streams.
The High TDS/ COD Effluents

The treatment system for treating High TDS/ COD effluents consists of Equalization,
Neutralization, Settling tank, Stripper, Multiple Effect Evaporator (MEE) followed by
Agitated Thin Film Dryer (ATFD). The organic distillate from the stripper is sent to cement
plants for co-incineration and aqueous bottom from stripper is sent to MEE followed by
ATFD for evaporation. The condensate from the MEE and ATFD are sent to ETP
(Biological). Salts from ATFD are disposed to TSDF.
The Low TDS/ COD Effluents:

These effluents along with the condensate from MEE and ATFD are treated in primary
treatment consisting of equalization, neutralization, and primary sedimentation followed by
secondary biological treatment consisting of aeration tank and clarifier.
The treated effluents after biological treatment are subjected to tertiary treatment in a
reverse osmosis (Double RO) system. Permeate from RO is reused for cooling tower and
rejects are sent to MEE followed by ATFD. Sludge from various units of Biological treatment
are thickened in sludge handling system and sent to TSDF. Schematic diagram of effluent
treatment system is presented in Fig 2.36. Details of treatment facilities are presented in

Table 2.42. Technical specifications of effluent treatment system are presented in Table 2.43
and 2.44 respectively.
Table 2.42 Details of Treatment Facilities
S.No Description Capacity of Unit (KLD)
Installed Total after Operating
Capacity Expansion Volume
1 Stripper 10 135 113.3
2 Multiple Effect Evaporator 10 200 161.2
3 Agitated Thin Film Dryer 5 50 39.8
4 Biological Treatment Plant 25 250 191
5 Reverse Osmosis Plant - I 20 250 191
6 Reverse Osmosis Plant - II 70 57.3

High TDS/COD
Equalization &
Neutralization
Org. Distillate to
Cement Ind./TSDF
Settling
Hazelo Lab Pvt. Ltd.,
tank
Sludge to Organic
TSDF Distillate
Stripper
Scrubber Effluent,
DM/RO Rejects
Oil
Skimmer
Multiple Effect Low TDS & Screen Equalization & Aeration
Clarifier
Evaporator COD Chamber Neutralization Tank
Condensate
2-111
Agitated Thin Holding
Film Dryer Filter Press Tank
Salts to TSDF
Sludge Filters
Drying Bed
Rejects Sludge Cake to
To MEE TSDF
Recycle Water
Collection Double Treated Water
Sump RO Plant Storage Tank
To Cooling Towers
Team Labs and Consultants

Environmental Impact Assessment Report
Fig 2.36 Schematic Diagram of Effluent Treatment System

Table 2.43 Technical Specifications of Effluent Treatment System after Expansion

S.No Description Unit After
Expansion
Stripper
1 Design Capacity KLD 135
2 Feed Rate Kg/hr 4000-6000
3 Specific Gravity of Feed ≈ 1.03
4 Initial Feed COD PPM 20000-50000
5 Feed Total Solid % 2.0-4.0
6 High Heating Temperature OC 95 – 100
7 High COD Condensate recovery LPH 150-200
8 Dry Saturated Steam requirement at 3.0Kg/cm2 (g) TPH 0.8-1.2
9 Cooling Water circulation rate for condenser m3/hr 1.2-2.5
10 Cooling Water Inlet Temperature OC 30 – 32
11 Cooling Water Outlet Temperature OC 38 – 40
Multiple Effect Evaporator (MEE)
1 Design Capacity KLD 200
3 Feed Concentration mg/l 30000-70000
4 Feed Temperature OC 30
5 Initial Solids % 5.0-8.0
6 Solids in Concentrate % 35.0-40.0
7 Concentrate Output Kg/hr 1500-2500
8 Water Evaporation Rate Kg/hr 5000-8000
9 Designed Water Evaporation Rate Kg/hr 6000
10 Dry Saturated Steam requirement at 6.0Kg/cm2 (g) TPH 3.0-4.0
11 Cooling Water Circulation Rate at 30 – 32OC m3/hr 10.0-15.0
Agitated Thin Film Dryer (ATFD)
1 Designed Capacity KLD 50
3 Initial Feed Solid Content % 35.0-40.0
4 Final Moisture in Dry Bag-gable Product % 2.0-3.0
5 Water Evaporation Rate Kg/hr 1000-1500
6 Designed Water Evaporation Kg/hr 1200
7 Solid Output in Bag-gable form at 5 – 6% moisture Kg/hr 600-800
8 Dry Saturated Steam requirement at 6.0Kg/cm2 (g) Kg/hr 100-150
9 Cooling Water Circulation Rate at 30 – 32OC m3/hr 0.1-0.2

Table 2.44 Technical Specifications of Biological Treatment Plant - Proposed

Data After Expansion
Flow from MEE + ATFD : 146.5 KLD
Boiler Blow down : 10.0 KLD
Cooling Tower Blow down : 26.0 KLD
Domestic : 8.5 KLD
Total Flow to Neutralization tank : 191 KLD
Design Capacity : 250 m3/day
Flow : 191 m3/day
BOD : 458 mg/l
COD : 4589 mg/l
Total Dissolved Solids : 513 mg/l
BOD load : 88.5 kg/day
COD load : 877 kg/day
Total Dissolved Solids : 98 kg/day
Neutralization Tank
Average flow : 20.2 m3/hr
Hydraulic retention time : 12 hrs. at peak flow
Volume : 250 m3
Tank : 2 no. Proposed based on Daily flow.
Aeration Tank - 1
BOD(yo) : 458 mg/l
% of BOD removed : 80
BOD Load : 17.7 kg/day
COD : 4589 mg/l
COD Load : 877 kg/day
Outlet BOD : 97 mg/l
MLSS : 6000 mg/l
F/M ratio : 0.18
Flow : 250 m3/day
Volume of the Tank : 191 m3
Check for Detention time : 22.6 Hours (12 - 24)
Assuming depth : 3.5 m (4.0+0.5 F.B)
Area of the tank : 67.13 m2
Width of the tank : 8.19 m
Length of the Tank : 4.10 m
BOD5 load in the aeration tank : 206.37
Oxygen is required for every Kg of BOD5 to be : 2.00 kgs
removed
Oxygen requirement for areation : 412.74 kg/day
O2 in Air % : 0.21 %
Density of Air : 1.20
Oxygen requirement : 50.00 m3/kg O2/day
Air Required : 20635.6 m3/day

: 502.2 cfm
Consider 35% excess considering the air required in the equalization tank.
Total air required : 684.52 Kg O2/day
Clarifier - 1
Design quantity : 250 m3/m2-day
Surface loading rate of average flow : 12 m2
Surface area provided : 20.8 m
length of the tank (2l=b) : 4.56 m (Say 4.5 m)
Width of the tank : 2.28 m (Say 2.5 m)
Aeration Tank - 2
BOD(yo) : 144 mg/l
% of BOD removed : 80
BOD Load : 29.3 kg/day
COD : 288 mg/l
COD Load : 59 kg/day
Outlet BOD : 29 mg/l
MLSS : 5500 mg/l
F/M ratio : 0.18
Flow : 250 m3/day
Volume of the Tank : 227.3 m3
Check for Detention time : 21.8 Hours (12 - 24)
Assuming depth : 3.5 m (4.5+0.6 F.B)
Area of the tank : 64.94 m2
Width of the tank : 8.06 m
Length of the Tank : 4.03 m
BOD5 load in the aeration tank : 29.25
Oxygen is required for every Kg of BOD5 to be : 2.00 kgs
removed
Oxygen requirement for aeration : 58.51 kg/day
O2 in Air % : 0.21 %
Density of Air : 1.20
Oxygen requirement : 50.00 m3/kg O2/day
Air Required : 2925.29 m3/day
: 71.87 cfm
Consider 35% excess considering the air required in the equalization tank.
Total air required : 97.03 Kg O2/day
Clarifier - 2
Design quantity : 250 m3/m2-day
Surface loading rate of average flow : 12 m2
Surface area provided : 20.8 m
length of the tank (2l=b) : 4.56 m (Say 4.5 m)
Width of the tank : 2.28 m (Say 2.5 m)

Holding tank
The flow from the each individual settling tank i.e., the supernatant liquid is let into the respective
Pre-Filtration Tank, which has a minimum 8 hours holding capacity. This tank is provided to hold
the treated effluent and give an even flow to the pressure sand filter.
Average flow : 20.8 m3/hr
Peak factor : 2 m3/hr
Peak flow : 41.7 m3/hr
Provide min 1.5 hours holding capacity.
Hence required volume of the tank : 62.5 m3
Pressure Sand Filter:

Vertical down flow type with graded/sand bed under drain plate with polysterene strains.
Flow : 250 m3/day
Rate of filtration assumed as : 15 m3/m2/hr
Requirement of treated water for usage in 20 hrs : 12.5 m3/hr
Dia of filter of 1 nos. : 1030.33 mm
Provide a Pressure Sand filter of 1100 mm say 1250 mm dia with sand as media over layer, under
drain pipe, laterals face piping etc.,
Activated Carbon Filter:

Vertical down flow type with graded/sand bed under drain plate with polysterene strains.
Flow : 250 m3/day
Rate of filtration assumed as : 15 m3/m2/hr
Requirement of treated water for usage in 20 hrs : 12.5 m3/hr
Dia of filter of 1 nos. : 1030.33 mm
Provide activated carbon filter of 1100 mm say 1250 mm dia with sand as media over layer, under
drain pipe, laterals face piping etc.,
Reverse Osmosis -1:

Design Capacity : 250 KLD
Operating capacity : 191 KLD
Recovery : 70%
RO Permeate : 133.7 KLD
RO rejects : 57.3 KLD
Reverse Osmosis - 2:
Design Capacity : 70 KLD
Operating capacity : 57.3 KLD
Recovery : 70%
RO Permeate : 40.11 KLD
RO rejects : 17.19 KLD

2.4.2 Air Pollution

The manufacturing process consists of reaction, separation and purification. Reactions are
conducted in closed reactors, while separation is conducted in centrifuge, filtration
equipment etc. Purification would be conducted in reactors or filtration equipment. The
transfer of materials will be through closed pipelines. Emissions from process operations are
released from reactions and from down stream operations like drying, crystallization,
filtration etc. The usage of boiler for steam generation and DG sets for emergency power
back up also release emissions.
2.4.2.1 Emissions from Utilities

The sources of air pollution are from proposed 2 x 10 TPH coal fired boiler, existing 1 x 2 TPH
and existing 1 Lakh K.Cal thermic fluid heater. Backup DG sets of 2 x 1000 KVA are
proposed in addition to existing DG sets of 1 x 250 KVA capacity to cater energy requirement
during load shut downs. Bag filter will be provided as air pollution control equipment for 2 x
10 TPH coal fired boilers. DG sets shall be provided with effectivestack height based on the
CPCB formula. The emission rates of PM, SO2, and NOx from each stack presented in Table
2.45. Technical specifications of bag filters for 10 TPH is presented in Table 2.46
Table 2.45 Emission Details of Pollutants from Stack
S. Stack Connected to Stack Dia of Temp. of Exit Pollutant Emission Rate
No Ht (m) stack at exhaust Velocity (g/sec)
top(m) gases (0C) (m/sec) SPM SO2 NOx
Existing
1 2TPH Coal Fired 15 1 180 4.5 1.12 0.04 0.13
Boiler
2 1 lakh K.Cal/hr 15 0.32 127 7.96 0.16 - 0.004
Thermic Fluid
heater
3 250KVA DG Set 4 0.2 320 5 0.004 0.002 0.01
Proposed
1 2X10 TPH Coal 35 1.45 190 6.05 0.63 0.72 0.3
Fired Boiler
2 2X1000KVA DG set 10 0.2 180 8 0.01 0.02 0.03

Table 2.46 Technical Specifications of Bag Filters

S.No Application Unit Value/Description
1 Boiler Capacity TPH 10
Fuel Coal
2 Gas Volume m3/hr@170 degC 28000
Gas Temperature Deg C 180
Outlet emission mg/Nm3 <50
Flange to flange pr. drop mmWC 140
Moisture Content % 8.7
No. of Bags 268
Filter area per bag m² 1.72
Total filter area m² 460
Air to cloth ratio m³/min/m² 1.15
3 Bags
Diameter ID, mm 160
Length mm 3650
Material Nomex
Max. operating temp. degC 190
4 Bag Cleaning
Compressed air required Nm3/Hr 5-7 kg/cm2
No. pulse cum solenoid valve 10
Size of pulse valve NB 40
5 Material of Construction
Casing MS
a Tube Sheet MS
Cage MS
Hopper MS
7 Terminal Points
Dirty air Inlet of Poppet Valve, Flanged end
Clean air Outlet of Bag Filter, Flanged end
Dust discharge RALV
Compressed air Inlet of Air Header
Electricals Power Supply for Timer 230 V Ac

2.4.2.2 Emissions from Process (Terms of Reference No. Sp. TOR (2))
The manufacturing process consists of reaction, separation and purification. The reaction is
conducted in closed reactors, while the separation is conducted in centrifuge, filtration
equipment etc. The purification would be conducted in reactors or filtration equipment. The
transfer of materials is through closed pipelines. Various sources of emissions are identified;
a. Process Emissions The process emissions contain Ammonia, Carbon dioxide, carbon
monoxide, Hydrogen, Hydrogen Bromide, Bromine, Hydrogen Chloride and Sulfur dioxide.
Ammonia, Hydrogen chloride, Hydrogen Bromide, Bromine and Sulphur dioxide are sent to
scrubber in series. Ammonium Chloride from ammonia scrubbing, Sodium chloride from
HCl scrubbing, Sodium bromide from HBr and Bromine Scrubbing and Sodium Bisulfite
from Sulphur dioxide Scrubbing are sent to ETP. The other gases Carbon dioxide and carbon
monoxide are let out into atmosphere following a standard operating procedure, while
Hydrogen gas is let out into atmosphere through a water column. The quantity of process
emissions is presented in Table 2.47. Schematic diagram of Scrubbing system is presented in
Fig 2.37. Technical Specifications of two stage scrubber is presented in Table 2.48.
Table 2.47 Quantity and Mode of Treatment of Process Emissions
Product Name Stage Name of Gas Quantity Mode of treatment
(Kg/Day)
Bupropion I Hydrogen Bromide 529.8 To Scrubber
Desvelofloxin I Carbon dioxide 41.8 Let out into atmosphere
Hydrogen 0.2 Let out into atmosphere
through water column
Divolproex sodium I Carbon dioxide 176.8 Let out into atmosphere
Esomeprazole Mg I Hydrogen Chloride 60.1 To Scrubber
Hydrogen 0.2 Let out into atmosphere
Rosuvastatin I Hydrogen 1.6 through water column
Sertraline Hcl I Hydrogen 5.8
Valaciclovir II Hydrogen 1.2
N2-(1-(S)-ethoxycarbonyl- II Hydrogen 4.4
3-phenylpropyl-N6-
trifluoro acetyl)-L-Lysine
2-[2--[3(S)-[3-[2- (7-chloro- I Carbon dioxide 11.6 Let out into atmosphere
2-quinolinyl) ethenyl]
phenyl]-3-hydroxypropyl]
phenyl]-2- propanol.

(S,S)-2,8-diazabicyclo[4.3.0] II Hydrogen 0.1 Let out into atmosphere

nonane IV Hydrogen 0.4 through water column
Aminohydroxy butyloxy II Carbon dioxide 12.8 Let out into atmosphere
diphenylhexane Hydrogen 0.6 Let out into atmosphere
III Hydrogen 0.1 through water column
Trans-4-(4-chlorophenyl) II Carbon monoxide 11.7 Let out into atmosphere
cyclohexane carboxylic
acid
Tert-butyl 2-((4R,6S)-6-((E)- III Bromine 23.4 To Scrubber
2-(4-(4-flurophenyl)-6-
isopropyl-2-(N- methyl
methane sulfonamido)
Pyrimidin - 5-yl)vinyl)-
2,2-dimethyl-1,3- dioxane-
4-yl-) acetate
5 Cyano Phthalide I Sulfur dioxide 547.3 To Scrubber
II Sulfur dioxide 439.2 To Scrubber
1,1-cyclohexane di I Ammonia gas 566.7 To Scrubber
aceticacid Carbon dioxide 733.3 Let out into atmosphere
3-Carbomylmethyl-5- I Ammonia gas 227.3 To Scrubber
methyl hexanoic acid Carbon dioxide 352.5 Let out into atmosphere
N-(2-Methyl-5- II Hydrogen 3.9
aminophenyl)-4-(3-
amine
Benzoic acid, 4-[(4-methyl- I Hydrogen Bromide 87.8 To Scrubber
1-piperazinyl) methyl] Ammonia gas 18.5 To Scrubber
dihydrochloride
2,3-Epoxy-2-methyl-N-[4- I Sulfur dioxide 62.2 To Scrubber
cyano-3-(trifluoromethyl) Hydrogen chloride 35.5 To Scrubber
phenyl]propanamide

Fig 2.37 Schematic Diagram of Scrubbing System
Table 2.48 Technical Specifications of Two Stage Scrubber

Type Packed Tower Scrubber Two Stage
MOC PP/FRP 5 mm PP+8mm FRP
Air Flow Rate 2500CFM
Inlet Temp. 350C
Inlet Gas Pressure Atmospheric
Batch 24 Hrs
Scrubbing medium for IstStage Water 10% NaOH Solution
Scrubbing medium for IIndStage Caustic Solution (or) Acid
Blower
MOC PPFRP
Capacity 2500CFM
Suction Pressure − 250mmWC
Discharge Pressure 60mmWC
HP/RPM 5HP/1900RPM
Circulation System
Flow Rate 15 M3/hr
Head 30 Meters
Motor Make FLP
MOC PP
Make Antico
Storage/ Recirculation Tank
Capacity 3 KL
Size 1700mm Dia X 2300mm Ht.
MOC PP/FRP

2.4.2.3 Diffuse Emissions

Emissions are also released from various operations of manufacturing like centrifuge,
drying, distillation, extraction etc. These emissions mainly contain volatile contents of the
material sent for processing. The emissions are normally passed through vent scrubber
before releasing into atmosphere to mitigate odour. The emissions from distillation are
passed through condensers, which mitigate odour. Vent condensers in series to reactors,
distillation columns, driers and centrifuge etc. are provided to mitigate VOC emissions
release. Other vents are connected to common headers and scrubbers. The transfer pumps
shall be provided with mechanical seals. The transfer of solvents shall be mainly by closed
pipeline systems, while drum transfer is by using air operated diaphragm pumps in closed
hoods. The charging of solid raw materials shall be by using closed hoppers to avoid dust
emissions and hazard of static electricity. Breather valves shall be provided to storage
tanks. Thermal insulation and condensers will be provided for storage tanks of low boiling
point solvents. The reactor or solvent storage tank vents when not in use shall be kept
closed.
2.4.2.4 Fugitive Emissions

Fugitive emissions are anticipated from equipment leakage and transfer spills. The
periodic maintenance program shall ensure integrity of equipment mitigating the
equipment leakage. The spills however shall be managed by adopting the spill
management scheme as mentioned in the respective MSDS. The fugitive emissions shall be
reduced by closed transfer and handling of all hazardous solvents and chemicals. The
ventilation system provided will reduce the health impact on employees by way of dilution
of work room air and also dispersion of contaminated air.
2.4.2.5 Solvent Use and Recycle (Terms of Reference No. Sp. TOR (1))
Solvents are used for extraction of products and as reaction medium. Solvents constitute
major consumable material of synthetic organic chemical manufacturing, mainly used as
reaction medium. The used solvents constitute major waste stream of synthetic organic
chemical manufacturing. Hence it is proposed to recycle the solvents by distillation for reuse

in process, thereby reducing the total solvent consumption in the plant and reducing the
waste quantity to be disposed. The distillation columns are mainly provided to remove
moisture and impurities from spent single solvents, and mixed solvents. The recycled single
solvents are reused in the process, while the mixed solvents are sold to end users.
Distillation process generates residues which are mainly organic in nature containing
significant calorific value, and can be sent to cement plants for co-incineration as fuel. The
total solvent balance product wise and stage wise is presented in Table 2.49 & 2.50
respectively. Schematic diagram of solvent recovery system is presented in Fig 2.38.
Table 2.49 Total Solvent Balance – Product Wise

S.No Product Name Quantity (Kg/Day)
Solvent Recovered Fugitive To waste Residue
Quantity loss water
1 Amlodipine Besylate 4250 4033 28.9 27.6 160.5
2 Bupropion HCl 13250 12832.3 57.1 27.5 333.2
3 Clopidogrel Hydrogen Sulfate 7700 7441.5 36.3 44 178.2
4 Desvelofloxin Succinate 4500 4356.5 20 38 85.5
5 Divolproex Sodium 2000 1940.0 5 0 55
6 Dulaxetine HCl 2922 2775.9 23.4 36 86.7
7 Esomeprazole Mg Trihydrate 13072 12478.4 104.6 122.9 366.1
8 Glimepiride 2300 2244.5 12.4 8.1 35
9 Mesalamine 0 0 0 0 0
10 Metaprolol 3500 3395 15.5 0 84.3
11 Pantoprazole Sodium 3850 3726.5 30.8 26.5 66.2
Sesquihydrate
12 Pragabalin 6000 5700 48 180 72
13 Rosuvastatin Calcium 2550 2468 20.4 21.4 40.2
14 Sertraline HCl 5150 4892.5 41.2 154.5 61.8
15 Tramadal 6500 6175 52 195 78
16 Valaciclovir HCl Monohydrate 12349.8 11999.3 55.9 60.3 234.3
17 4-[4-Chloro-1-oxobutyl]-2, 2- 3441.5 3331.8 8.3 6.4 95
dimethyl phenyl acetic acid
18 N2-(1-(S)-ethoxy carbonyl-3- 4500 4343 22.4 36.7 97.9
phenyl propyl-N6-trifluoro
acetyl-L-lysine
19 2-[2-[3(S)-[3-[2-(7-Chloro-2- 6150 5948.8 28 24.2 149.1
Quinolinyl)-ethenyl]phenyl]-3-
hydroxypropyl]phenyl-2-
propanol
20 2,8-Diazo bicyclo Nonane 12450 12054 58.9 0 317.2
21 2, 3, 4, 5-Bis-O- (1- 4950 4702.5 39.6 20.9 187

methylethylidene)-b-D-
fructopyranose
22 2-Acetyl Ethoxy acetyl methoxy 0 0 0 0 0
23 (1,1) Carbonyl di imidazole 8500 8287.5 42.5 0 170
24 (2S, 3S, 5S)-2-Amino-3-Hydroxy- 3000 2879.5 18 28.5 74
5-Tert-Butylcarbonyl Amino 1, 6-
diohenyl
25 Trans-4-(4-chlorophenyl)- 2450 2365.8 12 23 49.3
cyclohexane carboxylic acid
26 Guanine 0 0 0 0 0
27 Poly allyl amine HCl 0 0 0 0 0
28 Tert-butyl 2-((4R,6S)-6-((E)-2-(4- 6850 6576 13.7 68.5 191.8
(4-flurophenyl)-6-isopropyl-2-
(N- methylmethane
sulfonamido)Pyrimidin - 5-
yl)vinyl)-2,2-dimethyl-1,3-
29 5-Cyano Pthalide 10000 9600 20 28 352
30 1,1-Cyclohexanediacetic acid 8000 7760 20 47.8 172.2
31 Carbamyl Methyl-5-Methyl 3700 3589 5.5 22.3 83.3
hexanoic Acid
32 2',3'-Di-O-acetyl-5'-deoxy-5- 2950 2843.5 24.1 25.4 57
fluorocytidine
33 N-(2-Methyl-5-aminophenyl)-4- 9000 8730 26.5 79.5 164.1
(3-pyridyl)-2-pyrimidine amine
34 4-[(4-Methylpiperazin-1-yl) 1950 1891.5 4.9 19.5 34.1
methyl] benzoic acid diHCl
35 2, 3-Epoxy-2-methyl-N-[4-cyano- 4220 4075.2 29.4 42 73.4
3-(trifluoromethyl) phenyl]
propanamide
Total Worst Case: 20 Products 145585.3 140409.4 678.8 885.5 3586.3
on campaign basis

Table 2.50 Total Solvent Balance – Stage Wise

S.No Product Name Stage Name of Solvent Quantity (Kg/Day)
Solvent Recovered Fugitive To Residue
Quantity loss waste
water
1 Amlodipine Besylate I Methanol 1500 1425 12 9 54
Methylene Chloride 1200 1152 8.4 39.6
Ethyl acetate 800 736 3.2 8.8 52
Mono Methyl amine 750 720 5.25 9.8 14.9
2 Bupropion HCl I N-methyl Pyrrolidone 500 482.5 2.5 5 10
Methylene chloride 3000 2910 12 78
Toluene 3200 3104 12.8 83.2
Acetone 750 723.75 3.8 7.5 15
II Acetone 3000 2910 12 15 63
Methanol 2800 2702 14 0 84
3 Clopidogrel Hydrogen Sulfate I Methylene dichloride 800 772 4 24
Ethyl acetate 1000 970 4 5 21
II Ethyl acetate 1500 1448 7.5 15 30
Methyl isobutyl ketone 1200 1164 4.8 6 25.2
Methylene dichloride 2000 1930 10 60
Acetone 1200 1158 6 18 18
4 Desvelofloxin Succinate I Ethyl acetate 1500 1447.5 7.5 15 30
n-hexane 1000 970 4 26
Methanol 1200 1164 4.8 14.4 16.8
Isopropyl alcohol 300 292.5 1.2 3.6 2.7
II Isopropyl alcohol 500 483 2.5 5 10
5 Divolproex Sodium I Methanol 0 0 0 0 0
III Methanol 2000 1940.0 5 55
6 Dulaxetine HCl I Dimethyl sulphoxide 1722 1635.9 13.8 72.3
Ethyl acetate 1200 1140 9.6 36.0 14
7 Esomeprazole Mg Trihydrate I Methanol 2000 1900 16 60 24
Methylene dichloride 5472 5198.4 43.8 229.8

Acetic acid 600 570 4.8 18.0 7.2

Ethanol 2000 1900 16.0 26.0 58
Acetone 3000 2910 24.0 18.9 47
8 Glimepiride I Acetone 1200 1176 6.0 4.2 13.8
Dimethyl formamide 500 482.5 3.0 2.5 12
Methanol 400 392 2.0 1.4 4.6
Methyl isobutyl ketone 200 194 1.4 4.6
9 Mesalamine
10 Metaprolol Succinate II Toluene 1000 970 3 21.8
III Acetone 2500 2425 12.5 0 62.5
11 Pantoprazole Sodium Sesquihydrate I Acetone 900 873 7.2 5.7 14.1
Ethanol 1200 1164 9.6 7.6 18.8
Methlene dichloride 250 237.5 2 0.8 9.7
Diisopropyl ether 1500 1452 12 12.5 23.6
12 Pragabalin I Isopropanol 2000 1900 16 60 24
Chloroform 4000 3800 32 120 48
13 Rosuvastatin Calcium I Acetone 750 720 6 5.5 18.5
Ethyl acetate 1000 980 8 9.3 2.7
Ethanol 800 768 6.4 6.6 19
14 Sertraline HCl I Ethyl acetate 3000 2850 24 90 36.0
n-Butanol 1500 1425 12.0 45 18
Diisopropyl ether 650 617.5 5.2 19.5 8
15 Tramadal HCl I n-Propanol 3000 2850 24 90 36
Ethyl acetate 3500 3325 28 105 42
16 Valaciclovir HCl Monohydrate I Dimethyl amine 2500 2437.5 12.5 25 25
Dimethyl formamide 350 339.3 1.4 9.1
Acetone 2500 2437.5 100 52.5
Ethanol 3000 2925 12 63
II Methanol 1500 1447.5 7.5 15 30
Ethanol 2500 2412.5 12.5 20.3 54.8
17 4-[4-Chloro-1-oxobutyl]-2, 2- dimethyl I DMF 241.5 231.8 0.5 2.4 6.8
phenyl acetic acid

Toluene 400 384 0.8 4 11

II Methylene dichloride 800 776 2 22
Toluene 550 533.5 1.4 15
Methanol 600 582 1.5 17
III Methylene dihloride 150 145.5 0.4 4
Toluene 700 679 1.8 19
18 N2-(1-(S)-ethoxy carbonyl-3-phenyl I Methanol 2400 2316 12 24 48
propyl-N6-trifluoro acetyl-L-lysine II Ethyl acetate 2000 1930 10 12.2 47.8
Ethanol 100 97 0.4 0.5 2
19 2-[2-[3(S)-[3-[2-(7-Chloro-2- I Methanol 150 144.8 0.8 1.5 3
Quinolinyl)-ethenyl]phenyl]-3- Methylene dichloride 2500 2412.5 12.5 5.3 70
hydroxypropyl]phenyl-2-propanol Acetonitrile 400 386 2 0.4 12
II Methanol 300 289.5 1.5 3 6
Toluene 1800 1746 7.2 9 38
Hexane 1000 970 4.0 5 21
20 2,8-Diazo bicyclo Nonane I Methanol 750 720 1.5 0 28.5
Toluene 500 485 1.3 14
II Ethyl acetate 2500 2425 7.5 47.5
Methylene dichloride 1200 1164 3.6 32.4
III Tetrahydrofuran 3000 2910 15 75
Toluene 2500 2400 15 85
IV Methanol 2000 1950 15 35
21 2, 3, 4, 5-Bis-O- (1- methylethylidene)- I Acetone 800 760 6.4 6.6 27
b-D-fructopyranose n-Hexane 1000 950 8 0 42
Toluene 3000 2850 24 12.9 113
Isopropanol 150 142.5 1.2 1.4 5
22 2-Acetyl Ethoxy acetyl methoxy I
23 (1,1) Carbonyl di imidazole I Toluene 8500 8287.5 42.5 0 170
24 (2S, 3S, 5S)-2-Amino-3-Hydroxy-5- I Tetrahydrofuran 1000 945 10 13 32.0
Tert-Butylcarbonyl Amino 1, 6- II Methanol 500 480 2 6.5 12
diohenyl III Methanol 1500 1455 6 9 30

25 Trans-4-(4-chlorophenyl)-cyclohexane I Toluene 400 386 2 4 8

carboxylic acid Ethanol 250 241.25 1.3 2.5 5
Monochlorobenzene 500 482.5 2.5 5 10
II Ethanol 1000 965 5 10 20
Toluene 100 97 0.4 0.5 2
Hexane 200 194 0.8 1 4
26 Guanine I 0 0 0 0 0
27 Poly allyl amine HCl I 0 0 0 0 0
28 Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4- I Methanol 350 336 0.7 3.5 9.8
flurophenyl)-6-isopropyl-2-(N- Methylene dichloride 750 720 1.5 7.5 21
methylmethane sulfonamido) II Methylene dichloride 1000 960 2 10 28
Pyrimidin - 5-yl)vinyl)-2,2-dimethyl- III Methanol 800 768 1.6 8 22
1,3-dioxane-4-yl-) acetate Toluene 1800 1728 3.6 18 50
DIP 700 672 1.4 7 20
Hexane 600 576 1.2 6 17
Dimethyl sulfoxide 850 816 1.7 8.5 24
29 5-Cyano Pthalide I Toluene 2800 2688 5.6 28 78.4
II Methanol 1000 960 2 0 38
Ethylene dichloride 3500 3360 7 0 133
III Methanol 200 192 0.4 0 8
Di Methyl Formamide 2500 2400 5 0 95
30 1,1-Cyclohexanediacetic acid I Isopropyl Alcohol 5000 4850 12.5 35.5 102
Toluene 3000 2910 7.5 12.3 70
31 Carbamyl Methyl-5-Methyl hexanoic I Toluene 2500 2425 2.5 10.3 62.3
Acid Ethylacetate 1200 1164 3 12 21
32 2',3'-Di-O-acetyl-5'-deoxy-5- IV Tri ethylamine 200 194 0.5 2 4
fluorocytidine Methylene chloride 600 582 2.1 1.9 14
Di isopropyl ether 400 388 1.4 4 7
V Toluene 500 475 10 5 10
Dichloro methane 850 824.5 2.1 8.5 15
Isopropyl alcohol 400 380 8 4 8

33 N-(2-Methyl-5-aminophenyl)-4-(3- I n-butanol 2500 2425 6.3 20.3 49

pyridyl)-2-pyrimidine amine Isopropyl alocohol 2000 1940 7 14.2 39
Methanol 2000 1940 7 20 33
II Methanol 2500 2425 6.3 25 44
34 4-[(4-Methylpiperazin-1-yl) methyl] I Triethyl amine 150 145.5 0.4 1.5 2.6
benzoic acid diHCl Toluene 1800 1746 4.5 18 32
35 2, 3-Epoxy-2-methyl-N-[4-cyano-3- I Dimethylformamide 20 19.2 0.2 0.6
(trifluoromethyl) phenyl] II Toluene 1000 970 2.5 10 18
propanamide N,N-Dimethyl 1500 1455 5.3 15 25
acetamide
III Chloroform 800 776 2 8 14
Toluene 600 570 12 6 12
Dimethyl formamide 300 285 7.5 3 5

Fig 2.38 Schematic Diagram of Solvent recovery System

2.4.3 Solid Waste

Solid wastes are generated from the process, solvent distillation, wastewater treatment and
utilities. The effluent treatment system generates stripper distillate, ATFD salts and ETP
sludge. The process operations generate process residue, filter media, used catalysts,
activated carbon and inorganic residue. The recycling operation of distillation generates
solvent residue and spent mixed solvents. The utilities i.e., coal fired boiler generates ash
while DG sets generate waste oil and used batteries. All the wastes except coal ash are
considered hazardous. The other non hazardous wastes are container, packing material,
empty drums etc. The containers and drums are detoxified before disposing to authorized
buyers. The hazardous wastes of process residue, stripper distillate, solvent residue, and
activated carbon are sent cement plants for co-incineration, thereby reducing the load on
TSDF facility and reducing consumption of non renewable resource of coal in cement plant
kilns. Mixed solvents shall be sent to authorized recyclers/cement plant for co-incineration
while spent solvents are recovered within plant premises. The inorganic wastes, filter media,
used catalysts, salts from ATFD, and ETP sludge are sent to TSDF facility located at
Dundigal, Ranga Reddy district. The waste oil and used batteries are sold to authorized
recyclers. Coal ash is sold to brick manufacturers in the local area. The process wastes are
compiled for each product in Table 2.51. The stage wise generation process wastes is
presented in Table 2.52. The quantity of solid waste generated in the plant and the disposal
practice is presented in Table 2.53.

Table 2.51 Solid Wastes Generated from Process – Product Wise

S.No Name of Product Quantity (Kg/Day)
Organic Inorganic Solvent Spent Hyflow Pd/C Total
Residue Residue Residue Carbon
1 Amlodipine Besylate 161.8 12.0 160.5 20 354.3
2 Bupropion HCl 135.3 333.2 30 498.5
3 Clopidogrel Hydrogen 199.7 54.0 178.2 40 471.9
Sulfate
4 Desvelofloxin 50.2 85.5 0 15 150.7
Succinate
5 Divolproex Sodium 75.4 55.0 30 160.4
6 Dulaxetine HCl 114.2 86.7 20 220.9
7 Esomeprazole Mg 116.3 366.1 30 512.4
Dihydrate
8 Glimepiride 54.8 35.0 10 99.8
9 Mesalamine 27.3 53.1 0.0 20 100.4
10 Metaprolol Succinate 67.6 84.3 151.9
11 Pantoprazole Sodium 34.4 250.0 66.2 30 380.6
Sesquihydrate
12 Pragabalin 304.8 72.0 376.8
13 Rosuvastatin Calcium 26.8 40.2 25 92.0
14 Sertraline HCl 170.4 61.8 20 252.2
15 Tramadal 275.9 269.4 78.0 30 653.3
16 Valcyclovir 463.6 15.0 234.3 25 15 30 782.9
Hydrochloride
Monohydrate
17 4-[4-Chloro-1- 99.2 62.6 95.0 256.7
oxobutyl]-2,2- dimethyl
phenyl acetic acid
methyl ester
18 N2-(1-(S)-ethoxy 760.5 97.9 50 908.4
carbonyl-3-phenyl
propyl-N6-trifluoro
acetyl-L-lysine
19 2-[2-[3(S)-[3-[2-(7- 117.8 149.1 50 316.9
Chloro-2-Quinolinyl)-
ethenyl]phenyl]-3-
hydroxypropyl]phenyl-
2-propanol
20 2,8-Diazo bicyclo 258.9 835.0 317.2 35 1446.1
Nonane
21 2,3,4,5-Bis-O- (1- 187 187.0
methylethylidene)-b-D-
fructopyranose
22 2- Acetyl Ethoxy acetyl 414.8 0.0 414.8
methoxy ether

23 N,N-Carbonyl di 2238.6 170.0 2408.6

imidazole
24 (2S,3S,5S)-2-Amino-3- 159.5 74.0 28 20 281.5
Hydroxy-5-Tert-
Butylcarbonyl Amino
1,6-diohenyl
25 Trans-4-(4- 21.0 49.3 70.3
chlorophenyl)-
cyclohexane carboxylic
acid
26 Guanine 1198.5 2199.4 0.0 3397.9
27 Poly allyl amine HCl 50.4 0.0 50.4
28 Tert-butyl 2-((4R,6S)-6- 247.7 191.8 439.5
((E)-2-(4-(4-
flurophenyl)-6-
isopropyl-2-(N-
methylmethane
sulfonamido)Pyrimidin
- 5-yl)vinyl)-2,2-
dimethyl-1,3-dioxane-
4-yl-) acetate
29 5-Cyano phthalide 862.3 352.0 8 1222.3
30 1,1- 517.3 172.2 689.5
Cyclohexanediacetic
acid
31 Carbamyl Methyl-5- 202.6 12.0 83.3 297.8
Methyl hexanoic Acid
32 2',3'-Di-O-acetyl-5'- 97.0 8.0 57.0 10 5 177.0
deoxy-5-fluorocytidine
33 N-(2-Methyl-5- 303.6 164.1 50 517.6
aminophenyl)-4-(3-
amine
34 4-[(4-Methylpiperazin- 128.1 34.1 162.2
1-yl)methyl]benzoic
acid dihydrochloride
35 2, 3-Epoxy-2-methyl- 108.0 73.4 181.4
N-[4-cyano-3-
(trifluoromethyl)
phenyl] propanamide
Total (Worst Case Max 9121.7 3770.4 3586.3 368 78 200 16371.7
20 Products on
Campaign basis)

Table 2.52 Solid Waste Generated from Process – Stage Wise

1 Amlodipine Besylate
Stage Quantity(Kg/Day)
Organic Inorganic Solvent Spent Hyflow Catalyst Total
Residue Residue residue Carbon
I 107.9 12 160.5 20 300.4
Total 107.9 12 160.5 20 300.4
2 Bupropion HCl
I 66 186.2 252.2
II 69.3 147 30 246.3
Total 135.3 0 333.2 30 498.5
3 Clopidogrel Hydrogen Sulfate
I 97.5 54 45 196.5
II 102.2 133.2 40 275.4
Total 199.7 54 178.2 40 471.9
4 Desvelofloxin Succinate
I 40.2 75.5 15 130.7
II 10 10 20
Total 50.2 0 85.5 0 15 150.7
5 Divolproex Sodium
I 0 0 0
II 23.4 23.4
III 52.1 55 30 137.1
Total 75.4 0 55 30 0 0 160.4
6 Dulaxetine HCl
I 114.2 86.7 20 220.9
Total 114.2 0 86.7 20 220.9

7 Esomeprazole Mg Dihydrate
I 116.3 366.1 30 512.4
Total 116.3 0 366.1 30 512.4
8 Glimepiride
I 54.8 35 10 99.8
Total 54.8 0 35 10 99.8
9 Mesalamine
I 27.3 53.1 20 100.4
Total 27.3 53.1 0 20 100.4
10 Metaprolol Succinate
I 10.3 10.3
II 13.8 21.8 35.6
III 43.5 62.5 106
Total 67.6 0 84.3 0 0 0 151.9
11 Pantoprazole Sodium Sesquihydrate
I 34.4 250 66.2 30 380.6
Total 34.4 250 66.2 30 380.6
12 Pragabalin
I 304.8 72 376.8
Total 304.8 0 72 0 376.8
13 Rosuvastatin Calcium
I 26.8 40.2 25 92.0
Total 26.8 0 40.2 25 92.0

14 Sertraline HCl
I 170.4 61.8 20 252.2
Total 170.4 0 61.8 20 252.2
15 Tramadal
I 275.9 269.4 78 30 653.3
Total 275.9 269.4 78 30 653.3
16 Valcyclovir Hydrochloride Monohydrate
I 197.1 15 149.6 15 376.7
II 266.4 84.8 25 30 406.2
Total 463.6 15 234.3 25 15 30 782.9
17 4-[4-Chloro-1-oxobutyl]-2, 2- dimethyl phenyl acetic acid methyl ester
I 40.8 18 58.7
II 24.5 18.0 53.6 96.1
III 33.9 44.6 23.4 101.8
Total 99.2 62.6 95.0 0.0 0.0 0.0 256.7
18 N2-(1-(S)-ethoxy carbonyl-3-phenyl propyl-N6-trifluoro acetyl-L-lysine
I 269.1 48 317.1
II 491.4 49.9 50 591.3
Total 760.5 0 97.9 0 0 50 908.4
2-[2--[3(S)-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-hydroxypropyl] phenyl]-2-
19 propanol.
I 13 84.3 97.3
II 104.7 64.8 50 219.5
Total 117.8 0 149.1 0 50 0 316.9

20 2,8 -Diazo bicyclo Nonae

I 79.9 42.3 122.2
II 3.5 79.9 15 98.4
III 11.6 835 160 1006.6
IV 163.9 35 20 218.9
Total 258.9 835 317.2 0 0 35 1446.1
21 2,3,4,5-Bis-O- (1- methylethylidene)-b-D-fructopyranose
I 0 187 187
Total 0 0 187 0 187
22 2- Acetyl Ethoxy acetyl methoxy ether
I 414.8 414.8
Total 414.8 0 0 0 414.8
23 N,N-Carbonyl di imidazole
I 2238.6 170 2408.6
Total 2238.6 0 170 0 2408.6
24 (2S,3S,5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl Amino 1,6-diohenyl
I 12.9 32 10 54.9
II 81.6 12 8 101.6
III 65 30 10 20 125
Total 159.5 0 74 28 0 20 281.5
25 Trans-4-(4-chlorophenyl)-cyclohexane carboxylic acid
I 14.9 23 37.9
II 6.1 26.3 32.4
Total 21.0 0.0 49.3 0.0 0.0 0.0 70.3

26 Guanine
I 1198.5 2199.4 3397.9
Total 1198.5 2199.4 3397.9
27 Poly allyl amine HCl
I 50.4 50.4
Total 50.4 0 0 0 50.4
Tert-butyl 2-((4R,6S)-6-((E)-2-(4-(4-flurophenyl)-6-isopropyl-2-(N- methylmethane
28 sulfonamido)Pyrimidin - 5-yl)vinyl)-2,2-dimethyl-1,3-dioxane-4-yl-) acetate
I 1.5 30.8 32.3
II 3.7 28 31.7
III 242.6 133 375.6
Total 247.7 0 191.8 0 0 0 439.5
29 5-Cyano Phthalide
I 112.9 78.4 191.3
II 324.9 171 495.9
III 424.5 102.6 8 535.1
Total 862.3 0 352.0 0 8 0 1222.3
30 1,1-Cyclohexanediacetic acid
I 517.3 172.2 689.5
Total 517.3 0 172.2 689.5
31 Carbamyl Methyl-5-Methyl hexanoic acid
I 202.6 12 83.3 297.8
Total 202.6 12 83.3 297.8

32 2',3'-Di-O-acetyl-5'-deoxy-5-fluorocytidine
I 21.9 24.1 10 5 61
II 75.1 8 32.9 115.9
Total 97 8 57 10 5 177
33 N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine amine
I 104.4 120.3 224.7
II 199.1 43.8 50.0 292.9
Total 303.6 0 164.1 0 0 50.0 517.6
34 4-[(4-Methylpiperazin-1-yl)methyl]benzoic acid dihydrochloride
I 128.1 34.1 162.2
Total 128.1 0 34.1 162.2
35 2, 3-Epoxy-2-methyl-N-[4-cyano-3-(trifluoromethyl) phenyl] propanamide
I 9.3 0.6 9.9
II 33.2 42.3 75.5
III 65.5 30.5 96
Total 108.0 0 73.4 0 0 0 181.4

Table 2.53 Total Solid Waste Generated and Mode of Disposal

S.No Description Units Quantity Mode of
Permitted After Treatment/Disposal
Expansion
1 Solvent residue TPD 0.033 3.58 Sent to TDSF/Cement
2 Process Organic TPD 9.12 Plants for Co-incineration
residue
3 Stripper Distillate KLD 3.4
4 Spent Carbon Kg/day 33.33 368
5 Spent Solvents KLD 1 126.4 Recovered within the
plant premises.
6 Spent Mixed KLD 0.66 14 Sent to authorized
Solvents recovery units/Cement
plants for co-incineration
7 Inorganic residue TPD 3.77 Sent to TSDF
8 Hyflow Kg/day 78
9 Catalyst Kg/day 200
10 Evaporation salts TPD 1.33 11.92
11 ETP Sludge TPD 0.65
12 Ash from Boiler TPD 40 Sold to Brick
manufactures
13 Detoxified No.s/ 50 650 Sold to authorized
containers month vendors
14 Waste oil KLPA 5.88 Sent to Authorized
15 Used batteries No.s/Yr 20 Recyclers
2.4.4 Noise Pollution

Noise is anticipated from motors, compressors and DG set. The DG shall be kept in a
separate enclosed room with acoustic enclosure. The motors and compressors shall be
provided with guards and shall be mounted adequately to ensure the reduction of noise and
vibration. The employees working in noise generating areas shall be provided with
earmuffs. The employees shall be trained in the mitigation measures and personal
protection measures to be taken to avoid noise related health impacts.

Hazelo Lab Pvt.Ltd. Environmental Impact Assessment Report
CHAPTER 3.0 BASELINE ENVIRONMENTAL STATUS
3.1 Introduction
Collection of base line data is an integral aspect of the preparation of Environmental
Impact Assessment Report. Baseline data reflects the present status of environment
before initiation of any activity of project. The possible effects due to proposed
expansion of manufacturing of M/s. Hazelo Lab Pvt.Ltd., are estimated and
superimposed on the compiled baseline data subsequently to assess environmental
impacts. The study was conducted in the impact area; 10 km radius area surrounding
the project site, during December 2016 - February 2017. Studies were undertaken to
generate baseline data of Micrometeorology, Ambient air quality (AAQ), water
quality, noise levels, flora and fauna, land use, soil quality and socio-economic status
of the community were collected.
3.2 Land Environment

Land and soil constitute the basic components of physical environment. The location
of industrial project may cause changes in land, land use, soil and denudational
processes in different intensities contingent on sptial proximity of the activity and
receptors. Land and soil may get altered within the vicinity of 5 km radius and to a
lesser extent upto 10 km radial distance due to the proposed expansion project.
3.2.1 Physiography
The project site is located at Survey Number 240, 242, 243, 247, 248 and 249,
Dothigudem Village, Pochampally Mandal, Yadadri Bhuvanagiri District, Telangana.
The site is located at the intersection of 170 17’ 17” (N) latitude and 780 50’ 46” (E)
longitude. The site elevation above mean sea level (MSL) is 407 m. The site is
surrounded by open land in north, west and south directions and SVR Laboratries
Pvt. Ltd., in east direction. The nearest habitation form the site is Antammagudem
located at a distance of 0.65 km in east direction. The main approach road is
Dothigudem – NH9 at a distance of 0.2 km in west direction. National Highway-9 is
at a Distance of 2.8 Km in Southwest Direction to the site. The nearest Town is
Choutuppal at a distance of 5.6 km in southeast direction and nearest airport is
Shamshabad located at a distance of 44 km in southwest direction. Chinna Musi River
is passing from NW to NE at a Distance of 5.8 Km in NW direction to the site. There

are seven reserve forests in the study area; Lakkaram RF at a distance of 1.2 km in
south direction, Chauttuppal RF at a distance of 4.8 km in northwest direction,
Malkapuram RF at a distance of 2.2 km in west direction, Hafeezpura RF at a distance
of 7 km in southwest direction, Ailaupur RF at a distance of 6.7 km in southwest
direction, Meharnagar RF at a distance of 5.3 km in northwest direction and Jalalpur
RF at a distance of 6.7 km in northwest direction are in the impact area. There is no
National Park, Wildlife sanctuary, ecologically sensitive area, critically polluted area
and interstate boundary within the impact area of 10 km. The slope of the region is
from northeast to southeast direction. The area has mainly single crop agricultural
lands irrigated by tube wells. The Site Location photographs are presented in Figure
3.1. The Base map of the study area is presented in Figure 3.2.
Figure 3.1 Site Photograph – Hazelo Lab Pvt. Ltd.

(Terms of Reference No. 4(vii))

3.2.2 Geology (Terms of Reference No. 4(x))

Geology and general configuration of the Area
The study area is underlain by various geological formations like Archaen
Crystallines, Deccan Traps, Puranas, Laterites, and River Alluvia. The area is occupied
by peninsular gneissic complex of the Archean age comprisssing pink and grey
granites, granitic sanded geneisses, migmatities, pegmatites, quartz veins and dolerite
dykes. They occur in the form of domes, scarpes, massive, columnar blocks and ‘tors’
etc. scattered over a flat undulating country. Both massive granites and gneisses are
intruded positioned, dolerite dykes and quartzite and pegmatitic reefs.
The deccan trap constitute a number of layers of varying texture and thickness. The
traps are weathered and vesicular. Weathered basalts have medium permeability and
vesicular basalts have relatively high permeability. Small areas of basaltic strata are
present as “outliers” in granitic terrain. Laterites are found capping the weathered
basalts.
The Unconsolidated materials in granitic terrain consist of the “in-situ” weathered

remains of parent bedrock for the most part of the district. Those materials (including
soils) present at the ground surface over upland areas and valley sides range in the
thickness from few centimeters to 25 m, the average thickness is approximately 22 m.
Along the flood plains of stream courses weathered materials are overlain by
transported sediments, the combined thickness of which range up to 30m. The
average thickness is approximately 18m. In basaltic terrain, unconsolidated materials
comprise lateritised clay, weathered basalt inter-trappean clays, and alluvial
sediments. Thickness of weathered basalts capped by laterites range upto 30m.
Whereas the thickness of weathered basalts exposed at the ground surface
approximates to around 6m.
3.2.3 Hydrogeology (Terms of Reference No. 4(x))

Drainage Pattern
Hydrogeologically the study area can be grouped under hard rocks occupied by
granite and granitic gneisses; the ground water occurs under confined conditions in
the weathered mantle and under semi confined conditions in the joints, fractures,
crevices etc. of the fresh rock below. It’s occurrence is controlled by the intensity and

depth of weathering and by the presence of the joints and fractures, which vary from
place to place. The open place available for water to accumulate in fresh rock is
extremely limited, while the weathered zone, which is more porous carrying most of
the water that is available for development. The depth to water table in wells is
governed to a large extent by the topography, the water levels being shallow in wells
located in valleys than those located on high grounds.
The open wells existing in the study area are tapping weathered zone and range in
depth from 5 to 18 meters below ground level. Most of the wells fall within the depth
range of 5 to 10 meters, and about 30 percent of wells fall within the depth range of 10
to 15 meters. The yield of dug wells with 10 to 15 m depth ranges from 80 to 180
m3/day. The wells are capable of sustained yield of about 500 lpm with a draw down
ranging from 1 to 6 meters. The yield of bore wells range from 4000 to 20000
liters/hour.
In areas of massive and poorly weathered rocks the safe well yield is less than 1
ha.m/year. Lower values occur in uplands where the transitivity, effective available
draw down and maximum area of zone of influence of pumping wells are low,
conversely, highest values occur where those independent variables are highest.
3.2.4 Soils
Soil may be defined as a thin layer of earth’s crust that serves as a natural medium for
the growth of plants. It is the unconsolidated mineral matter that has been subjected
to and influenced by genetic and environmental factors such as parent materials,
climate, organisms and physico-chemical action of wind, water and sunlight, all
acting over a period of time. Soil differs from the parent materials in the
morphological, physical, chemical and biological properties. Also soil differs among
them in some or all the genetic or environmental factors, therefore, some soils are
yellow, some are black, and some are coarse textured. They serve as a reservoir of
nutrients for plants and crop and also provide mechanical anchorage and favorable
tilth. The land use and land cover map of the study is shown in Figure 3.3. It may be
noted that the land use land cover map reflects predominant agriculture nature of the
impact area, and also its dependence on tanks for irrigation.

The Soil characteristics include both physical and chemical parameters. M/s. Team
Labs and Consultants field team carried out soil survey to assess the soil
characteristics of the study area. Representative soil sampling was done at several
important locations and these locations are shown in Figure 3.4. Analytical data of
soil samples is presented in Table 3.1.

Figure 3.2 Base map of the study area

Figure 3.3 Land use and land cover of the study area (Terms of Reference No. 4(ix) & 5(ii))

Figure 3.4 Soil Sampling Locations

Table 3.1 Soil Analysis Data (Terms of Reference No. 6(viii)

Parameter Unit S-1 S-2 S-3 S-4 S-5 S-6 S-7 S-8 S-9
pH - 7.38 7.67 7.92 7.84 7.54 7.42 7.82 7.58 7.95
Electrical Conductivity (EC) dS/m 0.081 0.135 0.176 0.200 0.178 0.172 0.107 0.173 0.298
Bulk Density g/cc 1.11 1.18 1.18 1.18 1.05 1.18 1.25 1.33 1.11
Cation-Exchange Capacity (CEC) Col(+)/kg 1.1 2.7 1.5 1.9 1.6 1.9 1.6 1.7 2.7
Infiltration rate mm/hour 14 14 12 17 13 13 13 18 24
Porosity % 58 56 56 56 60 56 53 50 58
Water Holding Capacity (W.H.C) % 1.03 1.30 1.4 1.9 2.6 0.6 0.51 1.50 1.6
Moisture % 1.04 1.31 1.40 1.91 2.66 0.63 0.51 1.52 1.63
Organic Matter % 1.24 2.75 1.78 0.69 3.64 2.27 1.17 0.89 0.69
Carbonates % Nil Nil Nil Nil Nil Nil Nil Nil Nil
Sand % 50 44 36.842 50 45 40 41 44 59
Silt % 31 33 41 33 35 40 39 36 24
Clay % 19 22 22 17 20 20 20 20 17
Organic Carbon % 0.72 1.59 1.04 0.40 2.11 1.31 0.68 0.52 0.40
Nitrogen (as N) % 0.056 0.051 0.067 0.094 0.056 0.077 0.012 0.070 0.171
Carbon / Nitrogen Ration (C/N) - 12.9 31.0 15.5 4.2 37.8 17.1 56.9 7.4 2.3
Phosphorus (as P) % 0.157 0.262 0.236 0.157 0.367 0.210 0.210 0.183 0.262
Potassium (as K) mg/kg 100 212 43 223 99 148 274 157 68
Sodium (as Na) mg/kg 56 95 38 119 43 120 91 119 287
Calcium (as Ca) mg/kg 35 68 101 102 86 101 68 70 70
Magnesium (as Mg) mg/kg 53 165 82 31 84 61 21 53 107
Calcium/Magnesium ratio - 0.66 0.41 1.23 7.29 1.03 1.65 3.29 1.32 0.66
Sodium Absorption Ratio (SAR) - 1.72 1.83 0.80 0.88 0.95 2.68 2.71 3.08 6.27
Chlorides (as Cl) mg/kg 31 60 30 151 61 60 663 123 312
Sulphates (as SO4) mg/kg 1.8 10 4.4 11 7.2 4.2 8.8 10 21
Aluminium (as Al) mg/kg <10 <10 <10 <10 <10 <10 <10 <10 <10
Zinc (as Zn) mg/kg 34 10 22 14 18 14 14 17 14
Texture - Loam Loam Loam Loam Loam Loam Loam Loam Sandy loam
S1-Hazelo Lab Pvt. Ltd., S2-Antammagudem, S3- Dhotigudem, S4-Yellagiri, S5-Lakkaram,
S6-Chinna kodur S7-Jublakpalli, S8-Turkaguda andS9-Dharmaji gudem.

The test results of soil samples collected in the impact area are interpreted referring to
the book; “Interpreting soil test results”. The reference tables are presented in Table
3.2. The pH of soil samples ranges from slightly acidic to mildly alkaline. The cation
exchange capacity of the soils is very high (six Samples), contributed mainly by
Sodium exchangeable ions. The level of nitrogen in most of the soil samples is very
low while the potassium levels are low to excessive. The calcium magnesium ratios of
the sample reflect low Calcium in five samples and low magnesium in 1 sample.
Table 3.2 Soil Test Results – Reference Tables

General interpretation of pH measured Rating for Cation exchange Capacity
pH Range Classification CEC (Cmol)+)/kg
<4.5 Extremely Acidic Very low <6 *
4.51 -5.0 Very Strong Acidic Low 6-12
5.1-5.5 Strong Acid Moderate 12-25
5.6- 6.0 Moderately Acid High 25-40
6.1-6.5 Slightly acid Very High >40
6.6-7.3 Neutral Source: Metson (1961)
7.4-7.8 Mildily Alkaline * Soils with CEC less than three are often low in
7.9 -8.4 Moderately Alkaline fertility and susceptible to soil acidification.
8.5-9.0 Strongly Alkaline
>9.0 Very Strongly Alkaline
Source: Bruce and Rayment (1982).
Ca/mg Ratio Extractable Potassium (K)
Description K
<1 Ca Deficient low <150 ppm* (< 0.4 meq/100 g soil)
1-4 Ca (Low) medium 150–250 ppm (0.4–0.6 meq/100 g soil)
4-6 Balanced high 250–800 ppm (0.6–2.0 meq/100 g soil)
6-10 Mg (Low) excessive >800 ppm (>2.0 meq/100 g soil)
>10 Mg deficient
Source: Eckert (1987) Source: Abbott (1989)
Rating of Total Nitrogen
Rating (% by Description
W)
<0.05 Very low
0.05-0.15 Low
0.15-0.25 Modium
0.25-0.50 High
>0.5 Very High
Source: Bruce and Rayment (1982)

3.3 Water Environment
Industrial development of any region is contingent on the availability of sufficient

water resources, as most of the process industries require water for process or cooling
purposes. The potential for exploitation of ground water resources increases as
development of new projects increases in industrial and agricultural areas. With the
increasing industrialization and urbanization the possibilities of contamination of
surface water and ground water sources are rapidly increasing. The water resources
in the area broadly fall into following categories:
1. Surface Water resources: Streams and ponds, etc.
2. Ground Water resources: Accumulation in deeper strata of ground.
3.3.1 Surface Water Resources

Chinna Musi River is flowing from northwest to northeast direction and passing the
study area at a distance of 5.8 km in northwest direction. There are few surface water
bodies like natural lakes and tanks in the study area. These tanks are located in
southwest and southeast directions of the site. The drainage pattern of the impact
area is dendritic, and the flow in the northern part of impact area is mainly into a
major stream of Chinna Musi River, whereas the southern part is mainly draining into
tanks and flowing towards eastern direction. The digital elevation model map of the
study area is presented in Figure 3.5. It may be noted that the highest point of the
impact area is in the southocwestern part at 450 m above MSL in the forest region due
to hillks, while most of the impact area has MSL ranging from 360 to 380 m above
MSL. The drainage pattern of impact area is presented in Figure 3.6.
3.3.1.1 Surface Water Quality (Terms of Reference No. 6(iv)

The analytical results of water samples drawn from various locations in the study area
during are presented in Table 3.3.

Table 3.3 Water Analysis Data –Suraface Water

S.No Parameters Tangallapalli Units Method of Analysis IS 2296:1982
Cheruvu
1 Temperature 31 oC IS:3025 part 09:2002 NS
2 Colour 1 Hazen IS:3025 part 04:2012 300
3 Turbidity <0.1 NTU IS:3025 part 10:2006 NS
4 pH 7.00 - IS:3025 part 11:2006 6.5-8.5
5 Total Solids 386 mg/l IS:3025 part 15:2003 NS
6 Total Dissolved Solids 372 mg/l IS:3025 part 16:2006 1500
7 Total Suspended Solids 14 mg/l IS:3025 part 17:2006 NS
8 Total Hardness (as CaCO3) 210 mg/l IS:3025 part 21:2009 NS
9 Calcium (as Ca) 38 mg/l IS:3025 part 40:2009 NS
10 Magnesium (as Mg) 28 mg/l IS:3025 part 46:2009 NS
11 Sodium (as Na) 56 mg/l IS:3025 part 45:2003 NS
12 Sodium Absorption Ratio 2.0 - - NS
(SAR)
13 Potassium (as K) 11 mg/l IS:3025 part 45:2003 NS
14 Carbonate (as CO3) Nil mg/l IS:3025 part 51:2006 NS
15 Bi carbonate (as HCO3) 185 mg/l IS:3025 part 51:2006 NS
16 Alkalinity (as CaCO3) 185 mg/l IS:3025 part 23:2003 NS
17 Chloride (as Cl) 50 mg/l IS:3025 part 32:2007 600
18 Sulphates (as SO4) 31 mg/l IS:3025 part 24:2009 400
19 Nitrate Nitrogen (as NO3) 53 mg/l IS:3025 part 34:2009 50
20 Silica (as SiO2) 5.6 mg/l IS:3025 part 35:2003 NS
21 Fluoride (as F) 0.20 mg/l IS:3025 part 60:2008 1.5
22 Residual, Free Chlorine <0.2 mg/l IS:3025 part 26:2009 NS
23 Mineral Oil Nil mg/l IS:3025 part 39:2013 NS
24 Cyanide (as CN) <0.02 mg/l IS:3025 part 27:2003 0.05
25 Aluminium (as Al) <0.5 mg/l APHA-3500-Al NS
26 Arsenic (as As) <0.001 mg/l IS:3025 part 37:2003 0.2
27 Boron (as B) <0.1 mg/l IS:3025 part 57:2010 NS
28 Cadmium (as Cd) <0.01 mg/l IS:3025 part 41:2003 0.01
29 Total Chromium (as Cr) <0.02 mg/l IS:3025 part 52:2003 0.05
30 Hexavalent Chromium (as <0.03 mg/l IS:3025 part 52:2003 0.05
Cr6+)
31 Copper (as Cu) <0.01 mg/l IS:3025 part 42:2009 1.5
32 Iron (as Fe) 0.10 mg/l IS:3025 part 53:2009 50
33 Lead (as Pb) <0.01 mg/l IS:3025 part 47:2009 0.1
34 Manganese (as Mn) <0.01 mg/l APHA-3500-Mn NS
35 Mercury (as Hg) <0.01 mg/l IS:3025 part 48:2003 NS
36 Nickel (as Ni) 0.01 mg/l IS:3025 part 54:2003 NS
37 Selenium (as Se) <0.001 mg/l IS:3025 part 56:2003 0.05
38 Zinc (as Zn) <0.005 mg/l IS:3025 part 49:2009 15
42 Oil and Grease <5.0 mg/l IS:3025 part 39:2003 0.1
43 Dissolved Oxygen 4.2 mg/l Is:3025 Part 38:2003 4
44 Chemical Oxygen Demand 13 mg/l IS:3025 Part 58:2006 NS
45 BOD 3 days at 27±10C 4.3 mg/l IS:3025 Part 44:2003 3
46 Total Coliforms 39 MPN APHA9221A& 5000
/100 ml 922B:2012

3.3.2 Ground Water Resources

Ground water is the accumulation of water below the ground surface, caused by
rainfall and its subsequent percolation through pores and crevices. Percolated water
accumulates till it reaches impervious strata consisting of confined clay or confined
rocks. Occurrence of ground water is controlled by land form, structure and
lithology. Ground water abstraction is by means of dug wells, dug cum driven wells,
bore wells and open wells. Ground water resources are ample in the study area.
Every village has a number of bore wells large and small. The state authorities have
also provided tube wells fitted with hand pump for the drinking water requirement of
villages in the study area. Presently the drinking water needs are mostly met from the
ground water resources.
3.3.2.1 Quality of Ground Water (Terms of Reference No. 6(v)
The quality of ground water occurring in the geological formations in the study area is
generally good in most of the areas. The representative samples are collected from
various dug wells and bore wells in the study area. The water samples drawn from
various locations in the study area are presented in Table 3.4. The analytical results of
water samples drawn from various locations in the study area are presented in Table
3.5. The water samples drawn from various locations in the study area are presented
in Figure 3.7.
Table 3.4 Locations of Ground water Sampling

S. No Location Name Direction Distance From Site
Form site (Km)
GW-01. Project site -- --
GW -02. Antammagudem W 1.3
GW -03 Dhotigudem N 1.7
GW -04. Yellagiri SW 2.4
GW -05. Lakkaram SE 4.0
GW -06. Chinna Kondur NE 5.5
GW-07. Malkapuram SW 7.2
GW-08. Dharmajigudem SE 3.5

Figure 3.5 Drainage Pattern of the study area (Terms of Reference No. 4(xi))

Figure 3.6 Digital elevation map of the study area

Figure 3.7 Water Sampling Locations

Table 3.5 Water Analysis Data – Ground Water

Parameters GW-1 GW-2 GW-3 GW-4 GW-5 GW-6 GW-7 GW-8 GW-9 Units Method of Analysis IS
10500:2012
Standard
Temperature 30 30 30 29 31 34 30 27 28 oC IS:3025 part 09:2002 -
Colour 1 1 1 1 1 1 1 1 1 Hazen IS:3025 part 04:2012 5
Turbidity <0.1 <0.1 0.1 0.1 0.1 0.1 <0.1 <0.1 <0.1 NTU IS:3025 part 10:2006 1
pH 7.7 7.32 7.68 7.17 7.38 7.64 7.65 7.72 7.91 - IS:3025 part 11:2006 6.5-8.5
Total Solids 764 867 554 621 683 544 622 675 691 mg/l IS:3025 part 15:2003 NS
Total Dissolved Solids 745 851 541 601 666 532 606 664 672 mg/l IS:3025 part 16:2006 500
Total Suspended Solids 19 16 13 20 17 12 16 11 19 mg/l IS:3025 part 17:2006 NS
Total Hardness (as 565 694 260 468 442 270 315 543 213 mg/l IS:3025 part 21:2009 200
CaCO3)
Calcium (as Ca) 136 166 56 109 55 44 76 121 41 mg/l IS:3025 part 40:2009 75
Magnesium (as Mg) 55 68 29 48 74 39 30 59 27 mg/l IS:3025 part 46:2009 30
Sodium (as Na) 75 67 110 46 93 110 112 72 176 mg/l IS:3025 part 45:2003 NS
Sodium Absorption 1.5 1.2 3.4 1.0 2.4 3.5 3.1 1.5 6.1 - - NS
Ratio (SAR)
Potassium (as K) 2.6 1.7 11 3.0 0.75 5.7 12 1.9 2.0 mg/l IS:3025 part 45:2003 NS
Carbonate (as CO3) Nil Nil Nil Nil Nil Nil Nil Nil Nil mg/l IS:3025 part 51:2006 NS
Bi carbonate (as HCO3-) 160 265 180 168 213 183 188 490 110 mg/l IS:3025 part 51:2006 NS
Alkalinity (as CaCo3) 160 265 180 168 213 183 188 490 110 mg/l IS:3025 part 23:2003 200
Chloride (as Cl) 268 223 165 121 145 165 165 39 218 mg/l IS:3025 part 32:2007 250
Sulphate (as SO4-) 68 80 29 61 86 22 55 43 94 mg/l IS:3025 part 24:2009 200
Nitrate Nitrogen (as 35 71 28 101 74 26 33 24 37 mg/l IS:3025 part 34:2009 45
NO3)
Silica (as SiO2) 9 16 4 11 9 9 9 11 9 mg/l IS:3025 part 35:2003 NS
Fluoride (as F-) 0.7 0.6 0.4 0.5 0.6 0.4 0.1 0.8 0.8 mg/l IS:3025 part 60:2008 1.0
Residual, Free Chlorine <1.0 <1.0 <1.0 <1.0 <1.0 <1.0 <1.0 <1.0 <1.0 mg/l IS:3025 part 26:2009 0.20
Mineral Oil Nil Nil Nil Nil Nil Nil Nil Nil Nil mg/l IS:3025 part 39:2013 0.50
Cyanide (as CN) <0.2 <0.2 <0.2 <0.2 <0.2 <0.2 <0.2 <0.2 <0.2 mg/l IS:3025 part 27:2003 0.05
Aluminium (as Al) <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 mg/l APHA-3500-Al 0.03
Boron (as B) <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 mg/l IS:3025 part 57:2010 0.50
Cadmium (as Cd) <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 mg/l IS:3025 part 41:2003 0.003

Parameters GW-1 GW-2 GW-3 GW-4 GW-5 GW-6 GW-7 GW-8 GW-9 Units Method of Analysis IS
10500:2012
Standard
Total Chromium (as Cr) <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 mg/l IS:3025 part 52:2003 0.05
Hexavalent Chromium <0.05 <0.05 <0.05 <0.05 <0.05 <0.05 <0.05 <0.05 <0.05 mg/l IS:3025 part 52:2003 0.05
(as Cr6+)
Copper (as Cu) <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 mg/l IS:3025 part 42:2009 0.05
Iron (as Fe) 0.3 0.4 0.42 0.2 0.40 0.21 0.26 0.23 0.2 mg/l IS:3025 part 53:2009 0.30
Lead (as Pb) <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 mg/l IS:3025 part 47:2009 0.01
Manganese (as Mn) <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 mg/l APHA-3500-Mn 0.10
Zinc (as Zn) <0.5 <0.5 <0.5 0.53 <0.5 <0.5 <0.5 <0.5 <0.5 mg/l IS:3025 part 49:2009 5.0
GW1-Hazelo Lab Pvt. Ltd. site, GW2-Antammagudem, GW3-Dothigudem, GW4-Yellagiri,
GW5-Lakkaram, GW6-Chinna kodur, GW7-Jublakpalli, GW8-Turkaguda and GW9-Dharmaji gudem.
Note: All values are expressed in mg/l except pH.

3.4 Air Environment
3.4.1 Meteorology
Micro meteorological studies are simultaneously conducted with the air quality
monitoring. Meteorology plays a vital role in effecting the dispersion of pollutants,
once discharged into the atmosphere, their transport, dispersion and diffusion into the
environment. The meteorological data is very useful for interpretation of the baseline
information and for model study of air quality impacts also. Since meteorological data
show wide fluctuations with time, meaningful interpretation can only be drawn from
long term and reliable data. Such source of data is the Indian Meteorological
Department (IMD), which maintains a network of meteorological stations at several
important locations. The normal climatological data provided by IMD, summarizing
the data recorded during 1981 - 2010 is presented in Table 3.6.

Table 3.6 Meteorological data at IMD Station


3.4.2 Meteorological Station at Plant Site (Terms of Reference No. 6(i))
The micro meteorological data at the industry site is collected simultaneously with
ambient air quality monitoring. The station was installed at height of 10 meters above
the ground level and the same is located in such a way that there are no obstructions
facilitating free flow of wind. Wind speed, wind direction, humidity and temperature
are recorded on hourly basis in the study area. Salient features of micro
meteorological data collected are as follows:
1. Wind Direction and Speed:
The hourly wind speed and wind direction observations are computed during study
period of winter season and the same are presented in Table 3.7 and the wind rose
diagram is presented in Figure 3.8. The following observations can be made from the
collected data;
• Calm period is observed to be 16.62 % during the time of monitoring.
• The predominant wind direction is east.
• Other than predominant wind directions wind was blowing in eastsoutheast and
southeast.
• Mostly the wind speeds are observed to be in the range of 5-10 kmph and 10-15
kmph.
2. Temperature: It may be noted that the daily temperature variations were:

maximum temperature 36.4 ºC and minimum temperature 14.2 ºC.
3. Humidity: The daily relative humidity values are observed to range between 35 to
65%.
4. Rain Fall: (a) Maximum: 12 mm (b) Minimum: 0 mm

Table 3.7 Frequency Distribution of Wind Speeds and Wind Directions

Wind Speed (KMPH)
Direction Total
Calm 1-5 5-10 10-15 >15
N 4.35 0.79 5.14
NNE 4.12 1.20 5.32
NE 3.15 0.74 3.89
ENE 3.33 1.44 0.32 5.09
E 9.26 13.52 1.85 0.05 24.68
ESE 5.42 6.44 1.06 12.92
SE 5.65 3.43 0.56 9.63
SSE 1.11 0.32 1.44
S 1.02 1.02
SSW 0.42 0.09 0.51
SW 0.60 0.23 0.83
WSW 0.51 0.32 0.83
W 2.69 1.02 3.70
WNW 2.36 0.46 2.82
NW 2.55 0.05 2.59
NNW 2.92 0.05 2.96
Calm 16.62 16.62
Total 16.62 49.44 30.09 3.80 0.05 100.00
Monitoring Period: December 2016 - February 2017

WIND ROSE PLOT: DISPLAY:

Wind Speed
Direction (blowing from)
NORTH
30%
24%
18%
12%
6%
WEST EAST
WIND SPEED
(m/s)
>= 4.2
2.8 - 4.2
SOUTH
1.4 - 2.8
0.3 - 1.4
Calms: 16.62%
COMMENTS: DATA PERIOD: COMPANY NAME:
Start Date: 12/1/2016 - 00:00 M/s.Hazelo Lab Pvt.Ltd.,

End Date: 2/28/2017 - 23:00
MODELER:
M/s.Team Labs and

Consultants, Hyderabad.
CALM WINDS: TOTAL COUNT:
16.62% 2160 hrs.
AVG. WIND SPEED: PROJECT NO.:
1.06 m/s
WRPLOT View - Lakes Environmental Software
Figure 3.8 Wind Rose Diagram at Site

3.4.3 Ambient Air Quality

Air pollution means the presence in the outdoor atmosphere of one or more
contaminants or combinations thereof in such quantities and of such duration as are
or may tend to be injurious to human, plant or animal life or property. Air pollutants
include smoke, vapors, soot, fumes, gases, mist, odors, particulate matter, radioactive
material or noxious chemicals. The proposed industrial activity may generate a range
of different pollutants which are released into the atmosphere. These pollutants
disperse in the air shed contingent on the meteorology and may have a significant
impact on neighborhood air environment and air quality. Thus collection of base line
data of air environment occupies a predominant role in the impact assessment
statement. The ambient air quality status across the study zone forms basis for
prediction of the impacts due to the project. The data required for assessing air
quality impacts in and around neighborhood is achieved by designing such a
network, which encompasses micro meteorological conditions, quantity and quality of
emissions, locations, duration, resources/monitoring technology and operational
criteria. The optimal scheme for air quality monitoring should consider all the above
factors.
3.4.4 Scope of Field Study

The scope of baseline status of the ambient air quality can be assessed through a well-
designed ambient air quality stations network. An intensive ambient air quality
monitoring of the study area consisting of 10 km radius with the industry site as the
center point was carried out during the period. The ambient air quality was
monitored at eight locations in the study area. Figure 3.9 presents the locations of
ambient air quality monitoring stations. At each sampling station monitoring was
carried out for 24 hours in a day for 2 days a week, and for eight months. The air
pollutants monitored on 24 hourly basis are, Particulate Matter (Size Less than 10µm)
or PM10 µg/m3, Particulate Matter (Size Less than 2.5µm) or PM2.5 µg/m3, Sulfur
dioxide and Oxides of Nitrogen. Sampling and analysis of the above variables is
according to the guidelines of Central Pollution Control Board. The National Ambient
Air quality standards are presented in Table 3.8.

Table 3.8 National Ambient Air Quality Standards

Time Concentration in Ambient Air
Pollutant Weighted
IRR ESA Methods of Measurement
Average
Sulphur Dioxide (SO2), Annual* 50 20 - Improved west and Gaeke
µg/m3 24 Hours** 80 80 - Ultraviolet fluorescence
Nitrogen Dioxide Annual* 40 30 - Modified Jacob &
(NO2), µg/m3 Hochheiser (Nn-Arsenite)
24 Hours** 80 80 - Chemiluminescence
Particulate Matter Annual* 60 60 - Gravimetic
(Size Less than 10 µm) 24 Hours** 100 100 - TOEM
or PM10 µg/m3 - Beta Attenuation
Particulate Matter Annual* 40 40 - Gravimetic
(Size Less than 2.5µm) - TOEM
or PM2.5 µg/m3 24 Hours** 60 60 - Beta Attenuation
Ozone (O3) µg/m3 8 hours** 100 100 - UV Photometric
- Chemilminescence
1 hour** 180 180 - Chemical Method
Lead (Pb) µg/m3 Annual* 0.50 0.50 - AAS method after sampling
on EPM 2000 or equivalent
24 hours** 1.0 1.0 filter paper
- ED-XRF using Teflon filter
Carbon Monoxide 8 hours** 02 02 - Non Dispersive Infra Red
(CO) ng/m3 (NDIR)
1 hour** 04 04 - Spectroscopy
Ammonia (NH3) Annual* 100 100 - Chemilminescence
µg/m3 24 hours** 400 400 - Indophenol blue method
- Gas Chromotography based
continuous analyzer
Benzene (C6H6) µg/m3 Annual* 05 05
- Absorption and Desorption
followed by GC analysis
Benzo(o)Pyrene(BaP)– Annual* 01 01 - Solvent extraction followed
Particulate by GC analysis
Phase only, ng/m3
Arsenic (As), ng/m3 Annual* 06 06 - AAS method after sampling
Nickel (Ni), ng/m3 Annual* 20 20 on EPM 2000 or equivalent
filter paper
IRR-Industrial, Residential, Rural and Other Area, ESA- Ecological Sensitive Area
G.S.No.826 (E) dated 16th November, 2009. Vide letter no. F. No. Q-15017/43/2007-CPW.s
*Average Arithmetic mean of minimum 104 measurements in a year taken for a week 24 hourly
at uniform interval.
**24 hourly/8 hourly values should meet 98 percent of the time in a year.

3.4.5 Description of Sampling Locations
The location of ambient air quality stations is contingent on the meteorological status
of the area. Hence the micro meteorological data was collected before initiating the
ambient air quality monitoring. Table 3.9 presents the ambient air quality locations
and their distances and directions from the plant site.
Table 3.9 Locations of Ambient Air Quality Monitoring Stations

S.No Location Direction Distance from
Plant site (Km)
A-1 Plant site - -
A-2 Antammagudem W 1.3
A-3 Dhotigudem N 1.7
A-4 Yellagiri SW 2.4
A-5 Lakkaram SE 4.0
A-6 Chinna Kondur NE 5.5
A-7 Jalalapur NW 7.0
A-8 Koyalgudem SE 3.4

Figure 3.9 Ambient Air Quality Monitoring Locations

3.4.6 Ambient Air Quality Status (Terms of Reference No. 6(ii), (iii) & Sp. TOR (3))
The existing baseline levels with respect to Particulate Matter (Size Less than 10µm) or
PM10 µg/m3, Particulate Matter (Size Less than 2.5 µg/m3) or PM2.5 µg/m3, Sulphur
dioxide and oxides of nitrogen at 8 locations are presented in Table 3.10. The
parameters monitored at the site show the following variations; the voc and HC
values are observed below detectable limits, the other parameters of NAAQ standards
are found to be below detectable limits except for PM10, PM2.5, SO2 and NOx. It may
be observed that the all parameters at all stations are well within the limits prescribed
by Central Pollution Control Board.
Table 3.10 Summary Ambient Air Quality Status
Pollutant Maximum Minimum Mean 98 Percentile
AAQ-1) Location: Site
PM10 50 39 44.5 49
PM2.5 18 14 16.26 18
SO2 12 9 10.23 12
NOx 14 9 12.31 14
VOC in PPM 2.5 0.3 1.5 2.2
CO in PPM 0.6 0.1 0.5 0.5
AAQ-2) Location: Antammagudem
PM10 44 36 40.0 43
PM2.5 17 14 14.15 17
SO2 11 9 10.23 11
NOx 13 9 10.35 13
VOC in PPM 0.6 0.3 0.4 0.5
CO in PPM 0.3 0.1 0.2 0.3
AAQ-3) Location: Dhotigudem
PM10 43 32 37.5 42
PM2.5 18 13 13.02 18
SO2 11 9 9.85 11
NOx 13 9 12.16 13
VOC in PPM BDL BDL BDL BDL
CO in PPM 0.2 0.0 0.1 0.1
AAQ-4) Location: Yellagiri
PM10 42 35 38.5 41
PM2.5 16 13 14.25 16
SO2 10 9 9.24 9
NOx 13 9 12.15 13
CO in PPM 0.3 0.1 0.2 0.3
AAQ-5) Location: Lakkaram
PM10 40 25 32.5 39
PM2.5 16 13 14.85 16
SO2 10 9 9.47 10
NOx 11 9 9.74 11
CO in PPM 0.3 0.1 0.2 0.3

AAQ-6) Location: Chinna Kondur

PM10 44 33 38.5 43
PM2.5 17 13 14.25 17
SO2 11 9 9.35 11
NOx 13 9 11.95 13
CO in PPM 0.3 0.1 0.2 0.3
AAQ-7) Location: Jalalpur
PM10 39 27 33.0 38
PM2.5 18 13 14.32 18
SO2 11 9 9.49 11
NOx 12 9 10.26 12
CO in PPM 0.3 0.1 0.2 0.3
AAQ-8) Location: Koyalgudem
PM10 47 35 41.0 46
PM2.5 16 13 14.34 17
SO2 11 9 9.38 11
NOx 13 9 11.0 13
CO in PPM 0.3 0.1 0.2 0.3
Note: Pollutant concentrations are presented in µg/m³
VOC concentration measured as Isobutylene euivalent
3.5 Noise Environment (Terms of Reference No. 6(vii)

Noise is an unwanted sound without musical quality. Artificial noise and its impact
on environment, grown apace with advancing human civilization. Noise pollution is
equally hazardous to environment as air, water and other forms of pollution. Various
noise measurement units have been introduced to describe, in a single number, the
response of an average human to a complex sound made up of various frequencies at
different loudness levels. The most common scale is, weighted decibel dB (A), and
measured as the relative intensity level of one sound with respect to another sound
(reference sound).
The impact of noise depends on its characteristics (instantaneous, intermittent or

continuous in nature), time of day (day or night) and location of noise source. Table
3.11 shows the effects of different noise levels on human beings. The environmental
impact of noise can have several effects varying from noise induced hearing loss to
annoyance depending on noise levels.
The assessment of noise pollution on neighborhood environment due to industry was

carried out keeping in view, all the considerations mentioned above. The existing

status of noise levels is measured at eight locations at various villages within the
study area. Figure 3.10 presents noise level monitoring locations. The monitored
noise levels are shown in Table 3.12. Noise levels are observed to be with in the
prescribed limits of rural and residential areas. Noise levels are high at the traffic
junctions compared to the industrial and village areas. The highest noise levels are
observed at plant site i.e., 64 dB (A) during day time and extremely low at
Koyalgudem i.e., 36 dB (A) during night time in the study area at the time of
measurement.
Table 3.11 Effects on Human Beings at Different Noise Levels
Source Noise Level Effects
dB(A)
Large Rocket Engine (near by) 180 Threshold of Pains
Hydraulic Press ( 1 m ) 130
Jet take off (60 m) 120 Maximum vocal effort possible
Automobile Horn (1m) 120
Construction Noise (3m) 110
Jet Take off (600 m) 110
Shout, Punch, Press, Circular Saw 100 Very annoying
Heavy Truck (15m), Farm 90 Prolonged exposure
Machinery Endangers Lathes,
Sports Car, Noisy Machines hearing
loss
Automobile (15m) 80 Annoying
Freeway Traffic (15m) 70 Telephone is difficult, intrusive
Loud Conversations 60
Living Room in Home 50 Quiet
Power Station (15m) 50
Bed Room in Home 40
Soft Whisper (5m) 30 Very quiet
Tick of Wall clock (1m) 30
Low radio Reception 20
Whisper 20
Rattling of Leaves by Breeze 10 Barely audible
0 Threshold of hearing
Table 3.12 Equivalent Noise levels in the Study Area

S.No. Location Equivalent Noise Levels dB(A)
Leq day Leq night
1. Plant site 64 51
2. Antammagudem 51 40
3. Dhotigudem 48 39
4. Yellagiri 49 37
5. Lakkaram 50 38
6. Chinna Kondur 52 39
7. Jalalapur 52 39
8. Koyalgudem 49 36

Figure 3.10 Noise Sampling Locations

3.6 Socio Economic Environment (Terms of Reference No. 6(xi)

Industrial development reflects in social development, i.e., growth in infrastructure
facilities, growth in employment rates, increased demands for housing, and other
amenities etc., which will have a bearing on the socio economic status.
Socio-economic survey is conducted to ascertain the existing socio-economic status to

compare the same with the developments due to the project. Baseline data of
demographic characteristics- occupational status, literacy, health status and the access
to infrastructure facilities for social development in the project area has been studied
from the secondary data collected from census department by M/s. Team Labs and
Consultants.
Demographic characteristics of the study area falling within 10 km radius of the

project site have been compiled to assess the pre-project socio-economic status.
Secondary data has been collected from various government agencies i.e., chief
planning officer, Yadadri Bhuvanagiri district and other government departments of
forestry, irrigation etc., and Mandal Development Offices of the relevant government
departments. Census 2011 was complied and presented as follows.
3.6.1 Demography
The study area falls under the following mandals of Yadadri Bhuvanagiri (previously
part of Nalgonda district) district; Pochampalle, and Choutuppal. Study area
comprises of 27 revenue villages and 10 hamlets.
3.6.1.1 Population Distribution

The population distribution of the study area is presented in Table 3.13. The
population density in the study area is less reflecting the rural nature and lack of
irrigation facilities. The total population of the area is 154932 consisting of 79634
males and 75298 females. The population of the scheduled castes is 27966 consists of
14181 males and 13785 females, while the scheduled tribe population is 3077 consists
of 1564 males and 1513 females, which is 18.05% and 1.9 % of the total population
respectively.

Table 3.13 Population Distribution – Study Area

Category kms Total
0-3 3-5 5-7 7-10
Total Population 1796 8934 73535 70667 154932
Total Population – Male 936 4622 37572 36504 79634
Total Population – Female 860 4312 35963 34163 75298
Population <6 years 224 1118 8033 7905 17280
Male <6 years 112 601 4113 4147 8973
Females < 6years 112 517 3920 3758 8307
Scheduled Caste Population - Total 229 1670 13292 12775 27966
Male – SC 116 852 6713 6500 14181
Female – SC 113 818 6579 6275 13785
Scheduled Tribe Population Total 3 65 971 2038 3077
Male – ST 1 27 511 1025 1564
Female – ST 2 38 460 1013 1513
3.6.1.2 Literacy
Census operations consider a literate as a person who is above six years old and who
can write and read as per the census. Table 3.14 presents the literacy levels in the
study area. The population below six years old is 17280 consists of 8973 males and
8307 females, which is 11.15 % of the study area population. It may be observed that
the literacy levels among females in general are low compared to the literacy levels
among males. The percentage of literacy level in the study area among males is
75.87% and 53.64% among females. It may be observed that the literacy level among
females is comparatively less than males.
Table 3.14 Literacy Study Area

Category kms Total
0-3 3-5 5-7 7-10
Population <6 years 224 1118 8033 7905 17280
Male <6 years 112 601 4113 4147 8973
Females < 6years 112 517 3920 3758 8307
Total Literates 955 5073 42937 40578 89543
Male –Literates 594 3058 25556 24400 53608
Female – Literates 361 2015 17381 16178 35935
Total Illiterates 841 3861 30598 30089 65389
Male –Illiterate 342 1564 12016 12104 26026
Female – Illiterate 499 2297 18582 17985 39363

3.6.1.3 Employment/Occupation
Work is defined as participation in any economically productive activity - Physical/
mental. The work force is classified into three categories: a) main workers, b) marginal
workers and c) non-workers. Main workers are those who work for a substantial part
of the year for a living such as salaried employees, agricultural labor etc. Marginal
workers are those who worked the previous year but have not worked for a
substantial part of this year. Non-workers constitute students, housewives,
dependents, pensioners etc. Table 3.15 presents the population distribution for
employment.
It may be observed that a majority of the study area population falls in the non-
worker category among 52.25 % of the population and the marginal workers form
about 6.87% of the total population. The male female difference is also significant in
all the regions and in all the categories. There are few females among the workers
where as there are more non-workers and marginal workers among females.
Table 3.15 Employments - Study Area

Category kms Total
0-3 3-5 5-7 7-10
Total Workers 889 4404 34583 34105 73981
Total Workers – Male 503 2613 20750 20205 44071
Total Workers – Female 386 1791 13833 13900 29910
Total Main Workers 532 3829 30496 28475 63332
Main workers – Male 349 2439 19723 18656 41167
Main Workers – Female 183 1390 10773 9819 22165
Total Marginal Workers 357 575 4087 5630 10649
Marginal Workers – Male 154 174 1027 1549 2904
Marginal Workers – Female 203 401 3060 4081 7745
Total Non Workers 907 4530 38952 36562 80951
Non Workers – Male 433 2009 16822 16299 35563
Non Workers – Female 474 2521 22130 20263 45388
The main workers are further classified into; Total cultivators: those who engage a
single worker or his family member to cultivate land for payment in money, kind or
share; Agricultural labor: those who work in other’s lands for wages; Livestock,
forestry, fishing and allied activities; Workers involved in mining and quarrying;

Workers involved in manufacturing and processing industries in the house hold

industries; non house hold industries; construction workers; workers in trade and
commerce; workers involved in transport, storage and communication ; and other
services: government employees, teachers, priests, artists etc. Table 3.16 presents the
main workers distribution among the study area population.
Table 3.16 Main Workers - Study Area

Category Kms Total
0-3 3-5 5-7 7-10
Total Main Workers 532 3829 30496 28475 63332
Main workers – Male 349 2439 19723 18656 41167
Main Workers – Female 183 1390 10773 9819 22165
Total Cultivators 168 755 5526 5556 12005
Cultivators – Male 113 506 3655 4048 8322
Cultivators- Female 55 249 1871 1508 3683
Total Agriculture Labor 152 1344 8069 10116 19681
Agriculture Labor – Male 50 575 2934 4173 7732
Agriculture Labor – Female 102 769 5135 5943 11949
Total Household Workers 13 99 2406 918 3436
Household Workers – Male 11 50 1534 623 2218
Household Workers – Female 2 49 872 295 1218
Total Others 199 1631 14495 11885 28210
Others – Male 175 1308 11600 9812 22895
Others – Female 24 323 2895 2073 5315
It may be observed that over 12.7 % of the study area population is involved in
cultivation or agriculture labor, followed by other services to the tune of 18.21% which
is largely due to the proximity to Hyderabad town. Significant differences are
observed among the male and female workers, Female workers are found to be more
in agricultural activity largely due to more percentage of females being agricultural
labor.
3.6.2 Living Standards and Infrastructure

Sustainable development of any area is dependent not only the population but also on
the availability of infrastructure which leads to better living standards. The
infrastructure facilities are essential in providing education, awareness, health,
communication, potable water, transport etc. The standard of living is the sum of the

availability of the infrastructure to the subject community, wide variations in terms of

income, economic conditions and patterns of spending.
The infrastructure facilities available in the impact zone are reflecting the rural nature
of the entire study area.
I. Educational Facilities
The educational facilities available in the rural areas are meager, despite the proximity
to urban area of Hyderabad. There are 46 primary schools, 19 middle schools and 14
high schools in the study area. There is one junior college in the area. Four of the
villages in the study area do not have any educational facilities. The higher
educational need of the population is met by choutuppal.
II. Health facilities

The medical and health facilities available in the impact zone are inadequate; there is
no PHC, 11 PHS and no Child welfare centers and RP centers in the entire area. The
health needs of the population in this area are met by quacks and other semi qualified
persons.
III. Availability of Potable Water

The entire population in this area is dependent on ground water for drinking
purposes. About 14 villages in the study area are dependent on tube wells, while the
remaining villages are dependent on wells and hand pumps.
IV. Transport and Communication

Transport is essentially provided by the Telangana State Road Transport Corporation
(TSRTC). Most of the study area has excellent road network in all the villages except
in one village, which has kacha roads. TSRTC bus facility is available for the all the
villages. However it is observed that a number of private transport vehicles are
observed in the area connecting them to choutuppal.
V. Sources of Energy and Availability

The primary source of energy in the study area is electricity, and the entire study area
has electricity for agriculture and domestic purpose. The urban areas have LPG
facility for their cooking purpose. A significant number of people in the urban area

are also dependent on Kerosene for cooking purposes, which is contingent on the
vagaries of public distribution system. A majority of the rural area is mostly
dependent on Kerosene, dried cow dung cakes, wood from roadside trees for their
domestic energy needs.
VI. Post and Telegraph facilities

There are 27 post offices in the area and 27 post & Telegraph office in the study area.
Phone facilities however are extended to some of the villages.
VII. Housing
Census defines the house hold as a group of persons living together and sharing their
meals from a common kitchen. The number of households in the impact zone is
15181. The density of the households is approximately six. The traditional houses
made up of mud walls and covered by dry common grass and leaves of bourses are
commonly found in the rural area, which are not considered pucca houses. The
government has been augmenting the housing standards by constructing housing
colonies for various weaker sections of the society.
3.6.3 Land Utilization

Land use patterns can be prepared on the basis of revenue records though it is not an
exact indicator of the actual use of the land at a given time. Land use is presented
under the heads of area under forest cover irrigated land, area under cultivation and
cultivable wasteland in Table 3.17.
Table 3.17 Land Utilization Pattern
Category kms Total Area,
0-3 3-5 5-7 7-10 Ha
Land Under Miscellaneous Tree Crops etc. - 29 173 131 333
Forest 0 186 869 274 1329
Area under Non-Agricultural Uses 24 149 523 621 1317
Culturable Waste Land 75 248 1562 776 2661
Area Irrigated by Source 87 377 1255 2699 4418
Barren & Un-cultivable Land 103 322 2589 1544 4558
Unirrigated Land 344 2776 5660 7063 15843
Total 633 4087 12631 13108 30459
It may be observed that a majority of the study area is Unirrigated, followed by

Barren & Un-cultivable Land.

3.6.4 Project Economy

M/s. Hazelo Lab Pvt.Ltd., proposes to expand the manufacturing capacity from 10.5
TPM to 495 TPM by acquiring additional land area of 29.16 acres, total land area after
expansion is 33.485 acres.
There is a potential for direct/indirect employment of about 60 people during

construction phase and 100 during operation phase. It will be spending approximately
35 Lakhs of rupees every month on salaries providing bread and succor to 100
families additionally. The proposed project will also generate indirect employment to
the locals during construction phase. The employers will contribute to the provident
fund, ESI and provide facilities as per the relevant labor act.
The proximity of Choutuppal town will provide access to the extensive medical
facilities available apart from the ESI medical facilities to the employees and their
families. An industrial Canteen is established by the company.
It may be concluded that satisfactory amenities are available for the population of the
impact zone, while the amenities are available either within the village or at a
minimum distance of 1 km. The area also has large tracts of waste lands which can
be utilized for industrial development.
3.7 Flora and Fauna (Terms of Reference No. 6(x)

In order to assess the baseline status of the flora of the study area, field surveys were
undertaken during the winter season of 2016 - 2017. Primary data on flora was
collected from extensive field surveys during the study period. As far as the fauna is
concerned, both primary and secondary were used and validated basing on published
reports of the ZSI, Forest department and research papers.
3.7.1 Land use and land cover of the study area

The land acquired for the chemical plant is a rocky wasteland with scattered, stunted,
nonpalatable bushes. It is more or less a plain land with a gentle slope from south to
north. Vegetation, flora and fauna of the project site and its surroundings up to a
radius of 10 Km were studied during the winter season of 2016. A survey of the flora
and fauna of the project site and its environs up to a radius of 10 Km reveals the
absence of thick forests but open scrub type communities were very common. There

are no sanctuaries or national parks or biosphere reserves or any other protected or

ecologically sensitive areas within a radius of 10 Km from the plant site.
3.7.2 Land use and land cover of the plant site

There are no trees and it was not put to any productive use earlier. There are no
ponds or water bodies or any constructions within the area. The area is sparsely
colonized by Cassia auriculata, Alhagi camelorum, Carissa spinarum, Lantana camara,
Propsopis juliflora, Mimosa rubicaulis, Alangium salvifolium, Acacia leucophloea, Calotropis
procera, Calotropis gigantea, Maytenus emerginata, Canthium dicodccum, Benkara
malabarica, Catunaegam spinosa, Morinda pubescens, Vitex negundo, Waltheria indica,
Tephrosia purpurea, Breynia vitis-ideae, Phyllanthus reticulatus, Acacia cesia, etc. Apart
from these perennials, a few palatable grasses and nonpalatable weeds were also
present. Within the site a few isolated individuals of both palatable and non palatable
weeds represented by Hyptis suaveolens, Parthenium hysterophorus, Celosia argentia,
Sida acuta, Cassia occidentalis, Cassia tora, Cleome viscosa, Heliotropium indicum, Croton
bonplandianum, Amaranthus spinosus and Cassia occidentalis. Cymbopogon coloratus,
Heteropogon contortus, Erempogon foeveolatus, Dicanthium annulatus, Digera arvensis,
Chloris barbata, Dactyloctenium aegyptium, Iseilema laxum, Andrographis echinoids etc were
found in association with the perennials. But none of them belong to the rare or
endangered or endemic or threatened (REET) category.
3.7.3 Terrestrial Vegetation and Flora in the study area

The following open dry deciduous scrub forests were found within the 10Km
i). Lakkaram reserve forest towards South at a distance of 1.2 km, ii). Chauttuppal
reserve forest towards Northwest at a distance of 4.8 km, iii). Malkapuram reserve
forest towards west at a distance of 2.2 km, iv). Hafeezpura reserve forest towards
southwest at a distance of 7.0 km, v). Ailaupur reserve forest towards southwest at a
distance of 6.7 km, vi). Meharnagar reserve forest towards northwest at a distance of
5.3 km and vii). Jalalpur reserve forest towards northwest at a distance of 6.7 km.
Tall Palmyrah Palms (Borassus flabellifer) and Date Palms (Phoenix sylvestris) palm are
scattered in the wastelands and along the flield bunds. Prosopis juliflora was indeed
the most widespread and abundant wasteland species. Cassia auriculata was the most

common associate of Prosopis juliflora in large areas especially in wastelands. Sweet

lime, Sour lime, Sapota, Amla, Custard Apple and Guava are also cultivated. There
were no forests but few forest elements were found here and there. The tree flora of
the study area was represented by the common avenue, shade, fruit and ornamental
trees as listed in Table 3.18. There was nothing exceptional about the flora of the
study area. Thick ground vegetation represented by grasses and forbs could be found
on account of good monsoon.
Table 3.18 List of tree species found in the study area

Latin name Vernacular name occurrence
Acacia nilotica Nalla tumma Widespread
Acacia auriculiformis Auriculiformis As avenue tree and in pure
plantations
Acacia caesia Kirintha Common Wild shrub
Acacia leucophloea Tella tumma Widespread in wastelands
Acacia sundra Sundra Widespread in wastelands
Aegle marmelos Maredu Wild and also cultivated
Ailanthus excelsa Peddamaanu Avenue tree
Albizia lebbek Dirisanam Avenue tree
Alhagi camelorum Camel thorn Wild shrubs
Annona squamosa Custard apple Very common fruit tree
Azadirachta indica Vepa Avenue tree
Bauhinia racemosa Ari Avenue tree
Bauhinia variagata Mandari Avenue tree
Benkara malabarica Pedda manga Common thorny shrub
Bombax ceiba Booruga Avenue tree
Borassus flabellifer Taati / Taadi Extensive and abundant palm
Breynia retusa Chinna purugudu Common Wild shrub
Breynia vitis-ideae, Nalla purugudu Common Wild shrub
Butea monosperma Modugu Forests and in plains
Canthium dicoccum Nalla balusu Sporadic thorny bush
Canthium parviflorum Balusu Common thorny bush with edible
fruits
Cassia fistula Rela Avenue tree
Casuarina equisetifolia Sarvi (Sarugudu) Agro-forest species
Catunaregam spinosa Manga / Chinna Occasional thorny bush
manga
Chloroxylon sweitenia Billudu Remnant of forest species.
Cocos nucifera Coconut Cultivated.
Dalbergia sisso Sisso or seesum Widely grown
Desmodium pulchellum Deyyapu mokka Common Wild shrub
Diospyros melanoxylon Tunki Occasional
Eucalyptus spp. Jama oil Agro forest species.
Euphorbia caducifolia Brahma jemudu In dry rocky areas
Feronia elephantum Velaga Limited
Ficus benghalensis Marri Avenue tree

Latin name Vernacular name occurrence

Ficus religiosa Raavi Avenue tree
Hardwickia binata Yepi Remnants of forest.
Holoptelia integrifolia Nemali naara Common avenue tree
Lagerstroemia parviflora Chennangi Avenue tree
Leucaena leucocephala Subabul In plantations
Mangifera indica Mamidi Occasionally cultivated
Mimosops elengi Pogada Avenue tree
Moringa olivaefera Munaga Cultivated.
Muntingia calabura Wild cherry Avenue tree
Phoenix sylvestris Eetha Widespread
Phyllanthus emblica Usiri Cultivated
Phyllanthus eticulates Pulasari / Puliseru Common Wild shrub
Phoenix sylvestris Eetha Common along drains
Pithecellobium dulce Seema chinta Avenue and hedge plant
Polyalthia longifolia Ashoka Avenue tree
Polyalthia pendula Asoka Avenue tree
Pongamia pinnata Ganuga Extensively grown.
Prosopis juliflora English tumma Extensive and abundant
Prosopis spicigera Jammi chettu In dry areas.
Samanea saman Nidrabhangi Avenue tree
Sapindus emarginatus Kunkundu Extensively grown.
Spathodea companulata Flame of the forest Avenue tree
Sterculia foetida Adavi badam Avenue tree
Syzigium cumini Neradu Extensively grown.
Tamarindus indica Chinta Extensively grown.
Tectona grandis Teku Extensively grown.
Terminalia arjuna Tella maddi Avenue tree
Thespecia populnea Ganga Raavi Avenue tree
Vitex negundo Vaavili Wild road side bush
Ziziphus numularia Gotti Common degraded forests
Ziziphus rugosus Regu Wild and also cultivated
Prosopis juliflora appears to be the most extensive, widespread and dominant plant in
all vacant lands including roadsides. Cassia auriculata was quite conspicuous in the
open places within the Prosopis juliflora formation. Other prominent tree species
include Neem (Azadirachta indica), Tamarind (Tamarindus indica), Holoptelia integrifolia,
Ailanthus excelsa, Pongamia pinnata, Vitex negundo, Alhagi camelorum, Lantana camara,
Carissa spinarum, Ziziphus numularia, Calotropis procera, Calotropis gigantea, Waltheria
indica, Tephrosia purpurea, Breynia vitis-ideae, Phyllanthus reticulatus, Acacia caesia,
Desmodium pulchellum, Acacia chundra, Acacia leucophloea, Acacia nilotica and Diospyros
melanoxylon. The herbaceous flora was dominated by Senna uniflora, Tridax
procumbens, Cressa cretica, Hyptis suaveolens, Parthenium hysterophorus, Celosia argentia,
Sida acuta, Cassia occidentalis, Cassia tora, Cleome viscosa, Heliotropium indicum, Croton

bonplandianum, Amaranthus spinosus, Cassia occidentalis, Cymbopogon coloratus,

Heteropogon contortus, Erempogon foeveolatus, Dicanthium annulatus, Digera arvensis,
Cressa critica, Chloris barbata, Dactyloctenium aegyptium, Iseilema laxum, Andrographis
echinoids etc were the other common widely scattered herbaceous species. Cotton,
Paddy, Jowar and Red gram were the most widely cultivated crops in upland areas
without assured irrigation. Maize, Bajra, Tomato, Chillies, Castor etc were grown
occasionally. There were also orchards of Amla (Phyllanthus emblica) Sweet lime,
sapota, Guava and Custard apple. All the trees present in and around the site are the
common avenue trees which are present through out the State of Telangana as well as
in other Southern States. There were no Rare or endemic or endangered or threatened
(REET) species. None of the plant species listed in Red Data was found in the study
area. A list of trees and shrubs found in the study area of project site is given in
Table 3.19. Most of the trees, herbs and shrubs found in the study area were
common to many inland areas of Telangana. In addition to the above, several
herbaceous weeds were also found in association with crops and orchards.
Table 3.19 Comparative list of the Weed flora in the study area
+ indicates presence and – indicates absence
Name of the weed Family Plant site Buffer area
Abutilon crispum Malvaceae - +
Abutilon indicum Malvaceae - +
Acalypha lanceolata Euphorbiaceae - +
Acanthospermum hispidum Asteraceae + +
Achyranthes aspera Amaranthaceae + +
Aerva lanata Amaranthaceae + +
Ageratum conyzoides Asteraceae + +
Allmania longipdunculata Amaranthaceae + +
Allmania nodiflora Amaranthaceae + +
Alloteropsis cimicina Poaceae + +
Alternanthera sessilis Amranthaceae + +
Alternanthra pungens Amaranthaceae - +
Althaea rosea Malvaceae - +
Alysicarpus monilifer Fabaceae + +
Amaranthus spinosus Amaranthaceae + +
Amaranthus viridis Amaranthaceae + +
Amaranthus roxburghianus Amaranthaceae - +
(Amaranthus polygamus)
Amiscophacelus axillaries Commelinaceae + +
(Cyanoits axillare)
Ammania baccifera Lythraceae - +
Argemone mexicana Papavaraceae - +
Aristolochia bracteolata Aristolochiaceae - +


Bacopa monnieri Srophulariaceae - +
Bergia capensis Elantinaceae - +
Biophytum nervifolium Oxalidaceae - +
(=B.sensitivum)
Bothriochloa pertusa Poaceae + +
Brachiaria reptans Poaceae + +
Brachiaria romosa Poaceae + +
Brachiaria cruciformis Poaceae + +
Bulbostylis barbata Cyperaceae + +
Caesulia axillaris Asteraceae - +
Cardiospermum helicacabum Sapindaceae - +
Cassia occidentalis Caesalpinaceae - +
Cassia tora Caesalpinaceae + +
Cassia absus Caesalpinaceae + +
Catharanthus pusillus Apocyanaceae - +
Celosia argentea Amaranthaceae + +
Chamaesyce indica Euphorbiaceae - +
Chamaesyce serpens Euphorbiaceae - +
Chamaesyce thymifolia Euphorbiaceae - +
Chamaesyce hirta Euphorbiaceae + +
Chloris barbata Poaceae + +
Chloris montana Poaceae + +
Chloris villosa Poaceae + +
Chrozophora rottleri Euphorbiaceae + +
Cleome gynandra Cleomaceae + +
Cleome aspera Cleomaceae + +
Cleome viscosa Cleomaceae + +
Commalina benghalensis Commelinaceae - +
Corchorus tridens Tiliaceae - +
Croton bonplandianus Euphorbiaceae + +
Cyperus compressus Cyperaceae + +
Cyperus difformis Cyperaceae - +
Cyperus exaltatus Cyperaceae - +
Cyperus iria Cyperaceae - +
Cyperus rotundus Cyperaceae + +
Dactyloctenium aegyptium Poaceae + +
Digera arvensis Amaranthaceae + +
Digera muricata Amaranthaceae + +
Digitaria ciliaris Poaceae + +
Dinebra retroflexa Poaceae + +
Echinochloa colona Poaceae - +
Echinochloa crusgalli Poaceae - +
Echinochlpa procera Poaceae + +
Eclipta alba Asteraceae + +
Enocostemma axillare Gentianaceae + +
Euphorbia heterophylla Euphorbiaceae - +
Evolvulus alsionoides Convolvulaceae + +
Fimbristylis bisumbellata Cyperaceae - -
Fimbristylis miliacea Cyperaceae - +


Fimbristylis ovata Cyperaceae - +
Fimbristylis quinquangularis Cyperaceae - +
Fuirena ciliaris Cyperaceae - +
Gomphrena celosioides Amaranthaceae + +
Gomphrena globosa Amaranthaceae + +
Goniogyna hirta (Heylandia latebrosa) Fabaceae - +
Hedyotis puberula (Oldenlandia Rubiaceae + +
umbellata)
Heliotropium ovalifolium Boraginaceae + +
Hibiscus lobatus Malvaceae - +
Hibiscus platanifolius Malvaceae - +
Hygrophila auriculata Acanthaceae - +
Indigofera linifolia Fabaceae + +
Indigofera linnii Fabaceae + +
Indigofera tinctoria Fabaceae + +
Indoneesiella echinoids Acanthaceae + +
(Andrographis echinoids)
Justicia procumbens Acanthaceae + +
Kyllinga bulbosa Cyperaceae - +
Lagascea mollis Asteraceae - +
Leucas aspera Lamiaceae + +
Limnophyton obtusifolium Alismataceae - +
Ludwigia perennis (=L.parviflora) Onagraceae - +
Malachra capitata Malvaceae - +
Malvastrum coromandelianum Malvaceae - +
Melochia corchorifolia Tiliaceae + +
Monochoria vaginalis Pontederiaceae - +
Oxalis corniculata Oxalidaceae - +
Parthenium hysterophorus Asteraceae + +
Paspalum distichum Poaceae + +
Pavonia zeylanica Malvaceae + +
Phyla nodiflora Verbenaceae - +
Phyllanthus maderaspatensis Euphorbiaceae + +
Phyllanthus virgatus Euphorbiaceae + +
Phyllanthus amarus Euphorbiaceae + +
Physalis minima Solanacae - +
Polygala arvensis Polygalaceae + +
Portulaca tuberosa Portulacaceae - +
Portulaca oleracea Portulacaceae + +
Portulaca quadrifida Portulacaceae - +
Psoralea corylifolia Fabaceae - +
Schoenoplectus auriculatus Cyperaceae - +
Schoenoplectus lateriflorus Cyperaceae - +
Setaria pumila Poaceae - +
Sida acuta Malvaceae + +
Sida corifolia Malvaceae + +
Sida rhombifolia Malvaceae + +
Solanum surattense Solanacae + +
Solanum nigrum Solanacae - +


Sopubia delphinifolia Scrophulariaceae - +
Spermacoce pusilla Rubiaceae + +
Spermacoce articularis Rubiaceae + +
(Borreria hispida)
Sphaeranthus indicus Asteraceae + +
Sphenoclea zeylanica Sphenocleaceae - +
Stemodia viscosa Scrophulariaceae - +
Striga angustifolia Scrophulariaceae + +
Tephrosia villosa (=T.hirta) Fabaceae + +
Tephrosia procumbens Fabaceae + +
Tephrosia purpurea Fabaceae + +
Tragia plukenitti Euphorbiaceae - +
Tragus roxburghii Poaceae + +
Trianthema portulacastrum Aizoaceae + +
Trianthema triquetra Aizoaceae + +
Tribulus terrestris Zygophyllaceae + +
Trichodesma sedgwickianum Boraginaceae + +
(=T.amplexicaule)
Tridax procumbens Asteraceae + +
Triumfetta rhomboidea Tiliaceae + +
Triumfetta rotundifolia Tiliaceae + +
Urochloa panicoides Poaceae + +
Vernonia cineria Asteraceae - +
Vigna trilobata (Phaseolus trilobatus) Fabaceae + +
Waltheria indica Tiliaceae + +
Withania somnifera Solanacae + +
Xanthium strumarium Asteraceae + +
3.7.4 Terrestrial Fauna

As the vegetation is sparse and as there is lot of human activity and biotic
disturbances, no wildlife except the common wild and domesticated animal species
were found. There are a few common resident birds and no exotic migratory bird
habitats occur in the study area. As there are no reserve forests, sanctuaries or
wildlife habitats and as the area is widely cultivated, there are no wild animals of
REET category. A list of Mammals, Reptiles, Aves and Amphibians found or known
to occur in the study area are given in Table 3.20. All the species reported are of
common and widespread occurrence.
Table 3.20 List of vertebrate species either found or known to occur in the study
area
Common name Latin name Vernacular name Schedule
Mammals
Monkey Macaca mulatto Kothi II
Three striped squirrel Petaurista palmarum Ground squirrel IV


Common Mongoose Varanus indicus Mungisa IV
Fox Vulpes bengalensis Guntanakka IV
Greater Bandicoot Bandicota indica Pandikokku IV
House rat Mus muscuius Yeluka IV
Indian field rat Mus booduga Yeluka IV
Indian flying fox Pteropus giganteus Gabbilam IV
Indian hare Lupus nigricollis Kundelu IV
Jackal Canis aureus Nakka IV
Lesser Bandicoot Bandicota bengalensis Pandikokku IV
Wild boar Sus scroffa Adivi pandi III
Reptiles
Sand boa Eryx johni Rendu thalala
pamu
Krait Bungarus caeruleus Katla pamu Not listed
Russell’s viper Vipera russseli Raktha pinjari Not listed
Rat snake Ptyas mucosus. Jerripothu Not listed
Tree Snake Dryphis sp. Chettu pamu Not listed
Blind Snake Typholops sp. Guddi pamu Not listed
Monitor lizard Veranus monitor. Udumu IV
Chameleon Chameleon zeylanicus Usaravilli IV
Wall lizard Hemidactylus flaviviridis Balli Not listed
Garden lizard Calotes versicolor Tonda Not listed
Fresh water turtle Trionxy sp. Neetitabelu IV
Indian star tortoise Testudo elegans Mettatabelu IV
Aves
Cormorant Phalacrocorax higher, Cheruvukkai IV
Crow Corvus splendens Kaaki V
Jungle Crow Corvus macrohyuchos Advikaki IV
Crow pheasant Centrpus sinesis Mohka IV
Cuckoo Cuculus varus Kokila IV
Ring Dove Streptopelia decactao Kapothamu IV
Cattle Egret Bubulcus ibis Egret IV
Egret, Little Egretta garetta Karchi Eagle IV
Koel Eudynamis scolopaceus Kokila IV
Munia, Spotted Lonchura striata Tetai Munia IV
Munia,White-Throated Lonchura malabarica Sar munia IV
Myna, Black-headed Sturnus pagodarun Goruvanka IV
Myna, common Acridothers trists Saada goruvanka IV
Owlet Barred Jungle Galuciddum radiatuum, Adavi gudlaguba IV
Owl, Spotted Athene brama Gudlaguba IV
Parakeet Large Indian Psittacula eupatria Chiluka IV
Parakeet, Rose-ringed Psittacula krameri Ramachiluka IV
Partridge, Grey Francolinus pondicerianus Chakoramu or IV
Kouju
Pigeon, Blue Rock Columbia livia, Kabuther IV
Pigeon, Green Treron pheoenicoptera, Pavuramu IV
Indian Robin Saxicoloides fulicata Kalchuri IV
Swift, house Apus affinis Babila IV
Swallow, common Hirando rustica, Babil or IV


Vanakovela
Water hen Amauromis phoenicurus Neeti kodi IV
Weaver Bird, common Ploceus philippinus Baya IV
Amphibians
Ordinary frog Rana hexadactyla. Kappa IV
South Indian Toad Bufo melonosticatus Godrukuppa IV
Tree Frog Hyla arboria Chettu kappa IV
Burrowing frog Cacopus bystema Burada kappa IV
Tiger Frog Rana tigrina Kappa IV
3.7.5 Aquatic Flora and Fauna

There are no large rivers or perennial reservoirs in and around the project site within a
radius of 10 Km; the area is not an important habitat for aquatic flora or fauna. But
there are a few tanks and seasonal streams as well as a large number of ditches and
puddles which collect flood water during the rainy season. In addition to these village
tanks, drains, and paddy fields provide the aquatic habitat for a variety of very
common aquatic plants and animals. As the entire plant site is dry owing to the failure
of monsoon, there are no aquatic plants except a few semi aquatic species. All the
species listed in Table 3.21 is found in the study area only. All the species recorded are
common and none of them comes under REET category. A list of macrophytes found in
the area is given in Table 3.22.
Table 3.21 List of aquatic / semi aquatic macrophytes found in the study area
Latin name Family Status
Alternanthera philoxeroides Solanaceae Predominant
Aponogeton natans Aponogetonaceae Common
Azolla pinnata Azollaceae Scattered and common
Brachiaria mutica Poaceae Sporadic
Carex cruciata Cyperaceae Occasional
Centella asiatica Apiaceae In localized patches
Chrysopogon aciculatus Poaceae Occasional
Colocassia esculenta Araceae Occasional
Cynodon dactylon Poaceae Extensive and widespread
Cyperus arenarius Cyperaceae Locally abundant
Cyperus exaltatus Cyperaceae Locally abundant
Echinochloa colona Poaceae Occasional
Eichhornia crassipes Pontederiaceae Extensive and widespread
Hydrilla verticillata Hydrocharitaceae Prevalent
Ipomoea aquatica Convolvulaceae Extensive and widespread
Ludwigia perennis Onagraceae Occasional
Marsilia quadrifoliata Marsiliaceae Very common Pteridophyte
Nelumbo nucifera Nelumbiaceae Very common

Latin name Family Status

Nymphaea nauchali Nympheaceae Widely scattered
Nymphoides hydrophylla Nympheaceae Scattered
Nymphoides indica Nympheaceae Scattered
Ottelia alismoides Hydrocharitaceace Widely scattered
Oxalis corniculata Oxalidaceae Occasional
Paspalidium geminatum Poaceae Common
Phragmites karka Cyperaceae Dominant along boundaries
Pistia stratoides Araceae Widespread
Salvinia cucullata Salviniaceae Common
Typha angustata Typhaceae Extensive and widespread
Vallisneria spiralis Hydrocharitaceae Widespread
Table 3.22 List of fishes either caught by the fisherman or reported from the study
area
Common name Latin name
Catla Catla catla
Rohu Labeo rohita
Murrel Channa striatus
Murrel Channa punctatus
Wallago Wallago attu
Cat fish Mystus vittatus
Cat fish Hetyeropneustes fossilis
Mrigal Cirrhinus mrigala
Tilapia Oreochromis mossambicus
Murrel Channa striatus
Murrel Channa punctatus
Eel Anguilla bengalensis
Cat fish Mystus vittatus
Cat fish Hetyeropneustes fossilis

CHAPTER 4.0 IDENTIFICATION OF IMPACTS
4.1 Identification of Impacts

Identification of Impacts is one of the basic analytical steps of EIA for subsequent
prediction and evaluation of impacts. A number of methodologies are available for
the identification of impacts. `Net Work Method,' which follows the “Cause-
Condition-Effect” relationship, is adopted for identifying impacts due to the
proposed expansion of API manufacturing facility.
The generation of cause - condition - effect networks (chain of events) is

advantageous in recognizing the series of impacts triggered by the plant and its
expansion activities. Thus this method has provided a “road mass” type of approach
to the identification of second and third order effects.
The idea was to account for the project activity and identify the different types of
impacts that would initially occur. The next was to select each impact and identify
the impacts. The main advantage of this approach is that it allowed identifying the
impacts by selecting and tracing out the events as they may occur.
4.2 Impact Networks

The purpose of identifying the impacts is that it aids in making appropriate decision
to mitigate adverse consequences if any. It may be pointed out that the distinction
between magnitude and importance of impact should be appreciated. Thus the
degree of extensiveness and scale of impacts and the consequences based on value
judgments are generalized while identifying impacts; as it is imperative that the
impact will normally lead to a chain of reactions. The construction of network charts
brings out to certain extent the appropriate levels of risks that may occur due to the
interventions while interacting with hydrological, biological and social systems.
Figure 4.1 to 4.6 present the identified impacts for various components of
environment viz. air, noise, water, land and socio economic aspects. In the above-
mentioned Figure the lines mean -- "has an effect on."
4.2.1 Air Environment

The primary impact of air pollutants will be on the air quality. The chemical
composition of air may change drastically if dispersion is slow. This will lead to, if

pollution is for a shorter period, immediate health problems. If it continues for a

long period, it may also have an impact on climatic changes, ecological equilibrium
and economic production of crops. The impacts on air environment from the
expansion of the project shall be due to utility emissions, process emissions, diffuse
and fugitive emissions consisting of pollutants ranging from particulate matter to
VOC. The impacts due to the proposed expansion shall be felt mainly within the
plant area and the immediate surroundings. There shall be an increase in ambient
air concentrations, unless mitigative and control measures are adopted. The
mitigative and control measures of air pollution shall ensure that the impact on air
quality is local – within the site area and its surroundings, with low magnitude,
medium term duration (during plant operation), and an irreversible impact.
4.2.2 Water Environment

The impacts on water environment are due to abstraction of ground water, effluents
from process, utilities and domestic sources, and spillage of chemicals, effluents and
solid wastes during storage, transfer and due to spillages of the same. The impact of
these activities are both direct and indirect effecting both soil and water quality
leading to deterioration of production levels of both terrestrial and aquatic flora and
fauna, resulting in higher concentrations of chemicals in food chain. The impacts on
surface water quality shall be neutral, reflecting locally within the site, with low
magnitude short term impact mainly due to spillage scouring during monsoon
season’s first rain, which is reversible in short term. The impact on hydrology is
neutral as the proposed expansion does not involve any major construction activity.
The impact on hydrogeology shall be negative as it is proposed to utilize
groundwater in addition to recycled water for expansion, resulting in impacts at
regional level with medium magnitude for a medium term, continuous frequency,
and is reversible in the long term, contingent on the adoption of mitigation
measures.
4.2.3 Noise Environment

The impacts on noise environment are due to mechanical activities, and operation of
pumps, motors, and compressors, resulting in increased ambient noise levels.

Excessive noise will trigger health risks such as headaches, depression, deafness and
retardation of sensory mechanisms in the impact area population. The increase in
noise levels shall have neutral impact, restricted to within site area due to its low
magnitude and occasional frequency.
4.2.4 Land Environment

The change in the land use during and after construction phase is unavoidable.
However as long as it is not affecting the soil quality chemistry and sedimentation,
the impact is not an undesirable one. At the secondary level the impact will lead to
change of agricultural production and livestock. The proposed expansion does not
involve any major construction activity. The impact on land environment is mainly
due to accidental spillages of chemicals, effluents and wastes. The expansion project
has neutral impact on land environment, terrain and soils as there is no additional
land requirement, and the impacts if any are restricted to within the site with
negligible magnitude and is felt mainly during expansion work only. The
operational phase impacts shall be neutral due to effective implementation of
mitigative measures in handling, storing and transferring wastes, effluents and
chemicals.
4.2.5 Biological Environment

The particulate matter and chemical compounds tend to alter soil matrix and water
quality. The impact will be on the native biota leading to density reduction and
extinction of sensitive species. There may be change in the species diversity and food
chain. The expansion activity does not involve disturbance of land or habitat. The
impact on biological environment is neutral with the effect confined mainly to the
site area with low magnitude for a medium term with isolated frequency. There will
be neutral effect on wildlife as the project impact area is mainly suburban in nature.
4.2.6 Socio-economic Environment

Primarily, the impact is expected on the economic environment. The project
generates jobs both during construction and operation stages. There is scope of
multiplier effect on secondary and tertiary employment. The socio economic
structure will have a positive change and quality of life would improve due to

increase in urbanization and cosmopolitanism. The expansion shall have positive

impact on socioeconomic environment due to provision of employment both direct
and indirect and proposed CSR activities. The impact is positive and long term
contingent on the financial success of the project.
Figure 4.1 Impacts Network For Air Environment

Figure 4.2 Impacts Network For Noise Environment

Figure 4.3 Identification of Likely Impacts for Waste Water

Figure 4.4 Impacts Network For Land Environment

Figure 4.5 Impacts Network For Soil Micro Flora and Fauna

Figure 4.6 Impact Network For Socio-Economic And Cultural Environment

4.3 Prediction of Impact on Air Quality

4.3.1 Details of Mathematical Modeling
A large number of different mathematical models for dispersion calculations are in
practice in many parts of the world. Most of the models for prediction of downwind
concentrations are based on Gaussian dispersion. The principle behind the Gaussian
dispersion models is Gaussian probability distribution of concentration in both
vertical and horizontal cross wind directions about the plume central line.
Predictions of ground level concentrations of the pollutants were carried out based
on site meteorological data collected during the study period. For calculation of
predicted ground level concentrations, ISCST3 model of Lakes Environmental based
on USEPA, ISCST3 algorithms, was used; as it’s based on more sophisticated
algorithm incorporating deposition, better algorithm for area sources, etc.
Brief History of the ISC Models

The ISC3 models are based on revisions to the algorithms contained in the ISC2
models. The latter came about as a result of a major effort to restructure and
reprogram the ISC models that began in April 1989, and was completed in March
1992. The reprogramming effort was largely motivated by the need to improve the
quality, reliability, and maintainability of the code when numerous "bugs" were
discovered after the implementation of the revised downwash algorithms for shorter
stacks. However, the goals of the reprogramming effort also included improving the
user interface by modifying the input file structure and the output products.
Overview of New Features in the ISC3 Models

The ISC3 models include several new features. A revised area source algorithm and
revised dry deposition algorithm have been incorporated in the models. The ISC3
models also include an algorithm for modeling impacts of particulate emissions from
open pit sources, such as surface coal mines. The Short Term model includes a new
wet deposition algorithm, and also incorporates the COMPLEX1 screening model
algorithms for use with complex and intermediate terrain. When both simple and
complex terrain algorithms are included in a Short Term model run, the model will
select the higher impact from the two algorithms on an hour-by-hour, source-by-

source, and receptor by- receptor basis for receptors located on intermediate terrain,
i.e., terrain located between the release height and the plume height.
Some of the model input options have changed and newer input options have been
added as a result of the new features contained in the ISC3 models. The source
deposition parameters have changed somewhat with the new dry deposition
algorithm, and there are new source parameters needed for the wet deposition
algorithm in the Short Term model. There are also new meteorology input
requirements for use of the new deposition algorithms. The option for specifying
elevation units has been extended to source elevations and terrain grid elevations, in
addition to receptor elevations.
The utility programs, STOLDNEW, BINTOASC, and METLIST have not been
updated. While they may continue to be used as before, they are not applicable to
the new deposition algorithms in the ISC3 models. The salient features of the
ISCST3 model are presented below in Table 4.1.
Table 4.1 Salient Features of the ISCST3 Model

S.No Item Details
1 Model name ISCST3 (Based on USEPA algorithm)
2 Source Types Point, Area, Volume, Open Pits
3 Dispersion Equation Steady State Gaussian Plume Equation
4 Diffusion Parameters Pasquill Gifford Co-efficient
5 Plume Rise Briggs Equation
6 Time Average 1 hr to Annual/Period Has Short Term and Long Term
modeling options
7 Deposition Both Dry and Wet Deposition
8 Application Input Data:
(i) Source Data Stack co-ordinates
(ii) Receptor Data Grid interval, number of receptors, receptor elevations
(iii) Meteorological Hourly meteorological data i.e. wind speed, direction,
Data ambient temperature, stability and mixing heights
4.3.1.1 Model Formulation

The model uses the following steady state Gaussian plume equation. The basic
equation for calculating the concentration of pollutants for any point in x, y, z co-
ordinates is given below:
C(x,y,z,H) = Q/2π σy σz U exp[-1/2(y/σy)2] x [exp{-1/2(z-h/σz)2}
+ exp{-1/2 (z+H/σz)2}]

Where
C= Concentration of pollutants in mg/cu m
Q= Strength of emissions in g/sec.
H= Effective Height (m), i.e., physical height + plume raise
y, z= diffusion coefficients in y and z directions in m.
U= average wind velocity in m/sec.
The following assumptions are made in Gaussian dispersion model.
This model assumes no diffusion in the down wind direction and thus applicable to
a plume and not a puff of pollutant. The dispersion parameter values used for
horizontal dispersion coefficient and vertical dispersion coefficients are those given
in the “Work book of atmospheric dispersion estimates”. These dispersion
coefficients assume a sampling time of about 10 min., the height values of interest to
be in the lowest several hundred meters of the atmosphere, a surface corresponding
to the open country. The stacks are tall enough to be free from building turbulence
so that no aerodynamic down wash occurs. The given stability exists from ground
level to well above the top of the plume.
The Gaussian dispersion model has been tested extensively for its validity and found
to be reasonably applicable for different atmospheric conditions. BIS has also
adopted this basic plume dispersion model. Hence the same model is adopted for
predictions of downwind concentrations of pollutants in this report.
4.3.1.2 Meteorological Data

Data recorded by the weather monitoring station at site on wind speed, direction,
solar insolation, temperature and cloud cover at one hourly interval for three months
i.e. One full season has been used for computations.
Mixing Height
The mixing heights for ambient air quality predictions are adopted from Atlas of
Hourly Mixing Height and Assimilative Capacity of Atmosphere in India by S.D
Attri, Siddartha Singh, B. Mukhopadhya and A.K Bhatnagar, Published by Indian
Metrological Department, New Delhi. 2008. The mixing heights range from 300 to
1450 m during summer season. There is no record of inversion for this area
(Reference: Atlas of Hourly Mixing Height and Assimilative Capacity of

Atmosphere in India by S.D Attri, Siddartha Singh, B. Mukhopadhya and A.K

Bhatnagar, Published By Indian Metrological Department, New Delhi. 2008). There
is no record of inversion in this area as observed from the IMD data.
4.3.2 Plant Emissions

The sources of air pollution from the plants of M/s. Hazelo Lab Pvt.Ltd., and the
following units in the surrounding which sought expansion in the recent months,
i.e., SVR Laboratories Pvt. Ltd, Chemic Life Sciences (P) Ltd., V.J. Sai Chem and
Optimus Drugs Pvt. Ltd., are boilers and DG sets. The major pollutants generated
from the fuel combustion are SO2, NOx and Particulate Matter. Based on fuel
analysis and combustion details the emission rates of above pollutants are
calculated. The emission rates of SO2, NOx and Particulate Matter from each stack
are presented in Table 4.2.

Table 4.2 Emission Details of Pollutants from Stack

S. No Stack Connected to Stack Dia of Temp. of Exit Pollutant Emission Rate
Ht (m) stack at exhaust gases Velocity (g/sec)
top(m) (0C) (m/sec) PM SO2 NOx
Hazelo Lab Pvt. Ltd
Existing
1 2TPH + 0.6TPH Coal Fired Boilers 15 1 180 4.5 1.12 0.04 0.13
2 1 lakh k. cal/hr Thermic fluid heater 15 0.32 127 7.96 0.16 - 0.004
3** 250KVA DG Set 4 0.2 320 5 0.004 0.002 0.01
Proposed
1 2 x 10TPH Coal Fired Boilers 35 1.45 190 6.05 0.63 0.72 0.3
2** 2 x 1000KVA DG Set 10 0.2 180 8 0.01 0.02 0.03
SVR Laboratories (P) Ltd
Existing
1* 1TPH Coal Fired Boiler 15 1 180 4.5 0.56 0.24 0.25
2** 250KVA DG Set 4 0.2 320 5 0.004 0.002 0.01
Proposed
1 5TPH Coal Fired Boiler 30 0.5 130 8.5 0.12 0.04 0.03
2* 4TPH Coal Fired Boiler 25 0.5 125 7.2 0.096 0.032 0.024
3 4.0 Lac K. Cal Thermic Fluid Boiler 10 0.25 165 8.23 0.05 0.14 0.18
4** 2 x 1000KVA DG Set 10 0.15 151 13.86 0.01 0.02 0.03
Optimus Drugs Pvt. Ltd.
Existing
1 3 TPH Coal Fired Boiler 28 0.6 180 8.5 0.15 0.21 0.42
2 1.5 TPH Coal Fired Boiler 30 0.32 127 7.96 0.32 - 4.00E-04
3 2 x 500 KVA DG Set** 2 0.1 144 1.5 0.002 0.001 0.005
Proposed
1 2 x 6 PH Coal Fired Boilers 30 0.9 130 6.05 0.12 0.06 0.05
4** 1 x 1000KVA DG Set 10 0.15 151 13.86 0.01 0.02 0.03
VJ Sai Chem
Existing
1* 1TPH Coal Fired Boiler 15 1 180 4.5 0.56 0.24 0.25
2** 125KVA DG Set 2.5 0.1 250 5 0.003 0.001 0.006
Proposed

1 5TPH Coal Fired Boiler 30 0.5 130 8.5 0.12 0.04 0.03
2 500KVA DG Set 5 0.15 165 7.5 0.06 0.18 0.25
3** 250KVA DG Set 4 0.2 320 5 0.004 0.002 0.01
* shall be kept as standby ** DG set will be used during load shut down.
Effective stack height for 10 TPH Coal Fired Boiler

On PM Basis - Coal Fired Boiler Units Capacity
Boiler Capacity TPH 10
Coal Consumption Kg/hr 2056
Coal Consumption TPD 49.34
Ash Generation @ 45% of consumption TPH 0.93
Fly ash (5% of total Ash) TPH 0.05
Stack Height Calculated (PM) H= 74*(Q0.27) m 32.27
On SO2 Basis - Coal Fired Boiler
Sulphur Content in Coal % (by wt. Max.) 0.45%
SO2 Emission Rate Kg/hr 18.5
Stack Height Calculated (SO2) H= 14*(Q ) 0.3 m 33.6
Hence it is proposed to provide a 35 m height stack for the coal fired boiler.
Effective Stack height for 1000 KVA DG set
DG Set Capacity 1000 KVA
Stack Height Calculated H= 0.2(KVA)0.5 6.32 m
Hence it is proposed to provide a 10 m height stack for DG set.

4.3.2.1 Diffuse Emissions

Emissions are also released from various operations of manufacturing like
centrifuge, drying, distillation, extraction etc. These emissions mainly contain
volatile contents of the material sent for processing. The emissions are normally
passed through vent scrubber before releasing into atmosphere to mitigate odour.
The emissions from distillation are passed through condensers, which mitigate
odour. It is proposed to provide vent condensers in series to reactors, distillation
columns, driers and centrifuge etc. to mitigate VOC emissions release. Other vents
are connected to common headers and scrubbers. The transfer pumps shall be
provided with mechanical seals. The transfer of solvents shall be mainly by closed
pipeline systems, while drum transfer is by using air operated diaphragm pumps in
closed hoods. The effluent storage tank is a major source of diffuse VOC emissions,
and it is proposed to provide a closed tank for initial storage of untreated effluents,
with a scrubber connected to the storage tank vent.
4.3.2.2 Fugitive Emissions
Fugitive emissions are anticipated from equipment leakage and transfer spills. The
periodic maintenance program shall ensure integrity of equipment mitigating
equipment leakage. The spills however shall be managed by adopting the spill
management scheme as mentioned in the respective MSDS, spill control kit shall be
provided in storage, and production blocks. The fugitive emissions shall be reduced
by closed transfer and handling of all hazardous solvents and chemicals. The
ventilation system provided will reduce health impact on the employees by way of
dilution of work room air and also dispersion of contaminated air.
4.3.2.3 Air Quality Predictions (Terms of Reference No. 7(i)

Predictions of ground level concentrations of the pollutants were carried out based
on site meteorological data collected during the study period. For calculation of
ground level concentrations a grid of 10 km X 10 km with a receptor interval of 400
meters is considered.
The composition of particulate matter was obtained from USEPA AIRCHIEF AP-42
and the same was considered in determining the source concentration of PM10 and
PM2.5 for prediction purpose. The predicted maximum 24 hourly ground level

concentrations of Suspended Particulate Matter, PM10, PM2.5, SO2 and NOx and
distance of occurrence during different seasons of study period are presented in
Table 4.3.
It may be observed that the annual predicted maximum 24 hourly GLC’s of PM,
PM10, PM2.5, SO2 and NOx are 3.50, 1.43, 0.67, 5.2 and 7.48 μg/m3 respectively and the
maximum values are observed at a distance of 0.4 km from the center of plant site in
northwest direction. However it may be noted that the predicted values of the SO2
and NOx are based on the assumption that the DG sets are used constantly, where as
the DG set usage is only during load shut down from Southern distribution
company of Telangana limited.
The GLC’s are also predicted at air quality monitoring locations and the predicted
GLC’s are presented in Tables 4.4 and the cumulative concentrations at various
villages are tabulated in Table 4.5. It may be observed from the Table that the
predicted results show that the incremental rise over existing base line status of
ambient air quality is within the limits prescribed by CPCB for residential and rural
areas. Hence the control measures and height of stack is sufficient to disperse the
pollutants into the atmosphere and keeping the baseline levels within the prescribed
limits. The predicted ground level concentrations are graphically displayed for SPM,
PM10, PM2.5, SO2, and NOx respectively in Figure 4.7 – 4.11.
Table 4.3 Maximum Predicted 24 hourly GLC’s

S.No Parameter Predicted GLC (μg/m3) Distance (KM) Direction
1 SPM 5.97 0.5 NW
2 PM10 2.33 0.5 NW
3 PM2.5 1.05 0.5 NW
4 SO2 5.88 0.5 NW
5 NOX 6.19 0.5 NW

Table 4.4 Predicted GLC’s at Monitoring Locations

S.No Monitoring Direction Distance Predicted GLC (μg /m3)
Location (Km) SPM PM10 PM2.5 SO2 NO
x
1 Antammagudem W 1.3 1.68 0.67 0.30 1.70 2.37
2 Dhotigudem NW 1.7 1.26 0.50 0.23 1.56 2.00
3 Yellagiri SW 2.4 0.21 0.08 0.04 0.46 0.19
4 Lakkaram SE 4 0.30 0.12 0.05 0.23 0.26
5 Chinna Kondur NE 5.5 0.23 0.09 0.04 0.47 0.28
6 Jalalapur NW 7.0 0.68 0.27 0.12 0.51 0.73
7 Koyalgudem SE 3.4 0.20 0.08 0.04 0.45 0.17
Reserved Forests
1 Lakkaram RF SE 0.8 1.53 0.61 0.28 1.70 1.29
2 Chauttuppal RF NW 4.7 0.35 0.14 0.06 0.32 0.36
3 Malkapuram RF SW 2.6 1.31 0.52 0.24 0.49 0.70
4 Hafizpura RF SW 6.8 0.51 0.20 0.09 0.37 0.56
5 Ailaupur RF SW 6.9 0.18 0.07 0.03 0.13 0.18
6 Meharnagar RF NW 5.2 0.54 0.22 0.09 0.48 0.58
7 Jalalpur RF NW 7.1 0.54 0.22 0.10 0.49 0.63

Table 4.5 Cumulative Concentrations at Various Villages and Reserved Forests

Station Direction Distance Baseline Concentration Predicted GLC (μg/m3) Cumulative Concentration
(Km) (μg/m )
3 (μg/m3)
PM10 PM2.5 SO2 NOx PM10 PM2.5 SO2 NOx PM10 PM2.5 SO2 NOx
Antammagudem W 1.3 44 17 11 13 0.67 0.30 1.70 2.37 44.67 17.30 12.70 15.37
Dhotigudem NW 1.7 43 18 11 13 0.50 0.23 1.56 2.00 43.50 18.23 12.56 15.00
Yellagiri SW 2.4 42 16 10 13 0.08 0.04 0.46 0.19 42.08 16.04 10.46 13.19
Lakkaram SE 4.0 40 16 10 11 0.12 0.05 0.23 0.26 40.12 16.05 10.23 11.26
Chinna Kondur NE 5.5 44 17 11 13 0.09 0.04 0.47 0.28 44.09 17.04 11.47 13.28
Jalalapur NW 7.0 39 18 11 12 0.27 0.12 0.51 0.73 39.27 18.12 11.51 12.73
Koyalgudem SE 3.4 47 16 11 13 0.08 0.04 0.45 0.17 47.08 16.04 11.45 13.17
Reserve Forests
Lakkaram RF SE 0.8 0.61 0.28 1.70 1.29 0.61 0.28 1.70 1.29
Chauttuppal RF SE 4.7 0.14 0.06 0.32 0.36 0.14 0.06 0.32 0.36
Malkapuram RF SW 2.6 0.52 0.24 0.49 0.70 0.52 0.24 0.49 0.70
Hafizpura RF SW 6.8 0.20 0.09 0.37 0.56 0.20 0.09 0.37 0.56
Ailaupur RF SW 6.9 0.07 0.03 0.13 0.18 0.07 0.03 0.13 0.18
Meharnagar RF NW 5.2 0.22 0.09 0.48 0.58 0.22 0.09 0.48 0.58
Jalalpur RF NW 7.1 0.22 0.10 0.49 0.63 0.22 0.10 0.49 0.63

Figure 4.7 Isopleths Showing 24 Hourly GLC’s of SPM

Figure 4.8 Isopleths Showing 24 Hourly GLC’s of PM10

Figure 4.9 Isopleths Showing 24 Hourly GLC’s of PM2.5

Figure 4.10 Isopleths Showing 24 Hourly GLC’s of SO2

Figure 4.11 Isopleths Showing 24 Hourly GLC’s of NOX

4.3.2.4 Prediction of Concentration of Solvents in the Indoor Environment Due to

Solvent Loss and Fugitive Emissions
A simple Box Model (EVAPMOD) was used to calculate the solvent concentration in
the indoor environment. The methodology adopted was to calculate the
concentration for the product group which has the largest amount of solvent losses.
General Box Model:

Indoor air pollution models developed and used by USEPA and others consider the
conservation of air contaminant mass in a volume or "box" of workroom air.
Airborne concentrations are derived by solving the following general equation (Jay
jock, 1988):
C = (Ain - Aout) / Volume of Box ---------- (1)
Where
C = Concentration at time ti (assume C=0 @ t0 = 0)
Ain = Mass of contaminant that went into the box during time interval ti - t0
Aout = Mass of contaminant that left the box during time interval ti - t0
The diffusion coefficient and the generation rate of the contaminant were calculated
to arrive at the airborne concentration in the environment.
For the General Ventilation Model, the overall estimate of the airborne concentration
of a contaminant is obtained by use of following equation.
Cv = (1.7*105) Ta*G
M*Q*m
Where: C v = Contaminant concentration in workplace (ppm)
Ta = Ambient temperature of the air (°K)
G = Vapor generation rate (gm/sec)
M = Molecular Weight (gm/gm-mole)
Q = Ventilation rate (ft3/min)
m = Mixing factor (dimensionless)
Higher solvent loss and the predicted airborne concentrations of the various solvents
are tabulated in the Table 4.6.

Table 4.6 Solvent Loss and the Predicted Airborne Concentrations

S.No Name of Solvent Fugitive cv TLV
Loss ppm (ppm)
(Kg/day)
1 Acetic acid 4.8 2.4 10
2 Acetone 95.7 48.9 1000
3 Acetonitrile 2.0 1.4 40
4 Chloroform 34.0 8.4 50
5 Di isopropyl ether 20.0 5.8 250
6 Dichloromethane 84.8 29.6 50
7 Dimethyl Formamide 17.5 7.1 10
8 Dimethyl sulfoxide 17.5 6.6 50
9 Ethanol 63.2 40.6 1000
10 Ethyl acetate 112.3 37.8 400
11 Ethylene Dichloride 7.0 2.1 10
12 Hexane 18 6.2 50
13 Isopropyl alcohol 72.4 35.7 400
14 Methanol 92.9 86.0 200
15 N,N Dimethyl Acetamide 5.3 1.8 10
16 Tetrahydrofuran 25.0 10.3 200
17 Toluene 160.3 51.6 200
18 Methyl Iso Butyl Ketone 6.2 1.8 100
19 Monochlorobenzene 2.5 0.9 75
20 n-Butanol 18.3 9.3 100
21 N-Methyl-2-Pyrrolidine 2.5 0.7 540
22 Triethyl Amine 0.9 0.3 5
4.4 Prediction of Impact on Noise Quality

The sound pressure level generated by noise source decreases with increasing
distance from the source due to wave divergence. An additional decrease in sound
pressure levels also occurs with increasing distance from the source due to
atmospheric effect or interaction with the objects in the transmission path. This is
due to excess attenuation. The sound pressure level is also affected by medium of
travel and environmental conditions. The propagation model has been devised to
take into account these factors and predict the noise levels at various distances round
a single or a multiple source. The model uses the following formula as a basis for
such predictions.
(Lob) = (Lr) - (Ldiv) - (Latm)
Where (Lob) = Observed noise level at a distance R from source

(Lr) = Noise level of source measured at reference distance r
(Ldiv) = Loss due to divergence at distance R from source

= 20 log (R/r)
(Latm) = Attenuation due to atmosphere at distance R from the source.
= a x R/100, where a is atmospheric attenuation coefficient in
dB (A)/100m.
For hemispherical wave divergence in a homogenous loss free
atmosphere (Latm) = 0.
The total impact of all sources at particular place is then estimated by adding as the
contribution of noise from each of the following sources as follows;
i=n (Lob)i/10
(Leq) = 10 log Σ {10 }
i=1
Where n = total number of sources
The calculated noise levels are further super imposed (logarithmically) on the
background noise levels. The model assumes that the noise spectrum is mainly
centered on a spectrum of 1000 Hz and attenuation due to building materials is also
at the same frequency.
The major source of noise generation is DG set which emit noise level of maximum
90 dB (A) at a reference distance of 1m from the source. The predicted cumulative
noise levels due to the source and the existing level as calculated from the
logarithmic model without noise attenuation ranged between 55 and 75 Db (A) at
distances ranging between 8 to 15 m which falls within the plant boundary. There is
no residential area in the immediate surroundings of the plant up to a distance of 650
meters. The impact of noise on the population in the surrounding area will be
negligible.
4.5 Prediction of Impact on Water Quality

Water is essentially used for process, utilities and domestic purposes. The total fresh
water required of quantity 250.73 KLD after expansion will be drawn from ground
water in addition to recycled water of 175 KLD. No impact on water quality is
expected due to the discharge of effluents as zero liquid discharge in envisaged,
which ensures reuse of treated effluents for cooling tower makeup and scrubbers.
There is no usage of treated water for on land irrigation. The impact on
hydrogeology shall be negative as it is proposed to utilize ground water resulting in
impacts at regional level with medium magnitude for a medium term, continuous
frequency, and is reversible in the long term.

4.6 Prediction of Impact on Soil

The overall impact on soil is negligible as the treated effluent is not used for green
belt development, and the solid waste generated at various stages and ash are sent to
TSDF. Hazardous wastes and spillage of chemicals and wastewater may not
contaminate the soil and ground water, if necessary mitigation measures are
adopted. Green belt development surrounding the plant site would improve soil
quality and surrounding ecology and aesthetic appeal of the area. Trees will absorb
specific air pollutants, reduce noise pollution, reduce soil temperature, help in
holding moisture in the soil, attract more birds and overall will help in maintain the
homeostasis of the environment. Avenue plantation and greenbelt shall significantly
improve the environmental quality The enhancement of green belt density as part
of the expansion shall have positive impact in the long term.
4.7 Prediction of Impact on Socio Economics

The overall impact on the socio economic status is very positive, as the accrued
benefits are both direct and indirect. The direct benefits are increase in employment,
escalation of land prices due to increased activities and improved infrastructure,
which in turn have a bearing on the productivity, industrialization and socio
economic status of the surrounding area in particular and the state in general.
4.8 Impacts of the Industry on Flora and Fauna

The ecological factors that are considered most significant as far as the impact on
flora and fauna concerned are:
1. Whether there shall be any reduction in species diversity?
2. Whether there shall be any habitat loss or fragmentation?
3. Whether there shall be any additional risk or threat to the rare or endangered or
endemic or threatened (REET) species?
4. Whether there shall be any impairment of ecological functions such as
(i) disruption of food chains,
(ii) decline in species population and or
(iii) alterations in predator-prey relationships?
5. Whether it is possible to attain the global objectives of ‘no net loss’ of biodiversity?

6. Whether it is possible to improve the biological diversity through the proposed

activity?
There is no direct threat to to any rare or endangered or threatened biological species
as indicated by the baseline data, due to the proposed expansion project, as it entails
least impact on vegetation. The project is not going to cause any fragmentation of
habitat or disruption of food cycles or destruction of breeding grounds or blockade of
migratory routes. The major impacts of the project are mainly during construction
and subsequently on account of atmospheric pollution. The industry is required to
limit its emissions as per the NAAQ of 2009. It has to strictly adhere to the conditions
stipulated by the regulatory bodies. The project authorities are going to take all steps
and measures in order to strictly comply with National Ambient Air Quality
Standards of 2009. The project may not have impacts on terrestrial flora and fauna.
Further, as there are no rare or endangered or threatened (REET) species within the
impact area, the project does not pose any direct threat to the survival of any rare
species. Hence, the proposed project activity is unlikely to pose any additional threat
to REET species either in the impact area.
4.9 Prediction of Impact on Vehicular Traffic

As the plant is located 2.8 km from the national highway there will not be any
unauthorized shop or settlements along the road connecting the plant site. The
traffic density of the adjacent road is medium mainly consisting of local agro
produce transport, commercial and passenger vehicle traffic. Raw materials and
finished products are transported by road using road trucks. The additional traffic
generated due to the establishment of the plants shall be 10-12 truck trips per day.
There will be marginal increase in the traffic density.

5.0 ENVIRONMENTAL MONITORING
5.1.1 Introduction
The environmental monitoring programme provides such information on which

management decision may be taken during construction and operation phases. It
provides basis for evaluating the efficiency of mitigation and pollution control
measures and suggest further actions that need to be taken to achieve the desired effect.
The monitoring includes:
(i) Visual observations;
(ii) Monitoring of environmental parameters at specific locations;
(iii) Sampling and regular testing of these parameters.
5.1.2 Objectives
The objectives of the environmental monitoring programme are:
• Evaluation of the efficiency of mitigation and pollution control measures;
• Updating of the actions and impacts on baseline data;
• Adoption of additional mitigation measures if the present measures are
insufficient;
• Generating the data, which may be incorporated in environmental
management plan in future projects.
5.1.3 Methodology
Monitoring methodology covers the following key aspects:

• Components to be monitored;
• Parameters for monitoring of the above components;
• Monitoring frequency;
• Monitoring standards;
• Responsibilities for monitoring;
• Direct responsibility,
• Overall responsibility;
• Monitoring costs.
5-1 Team Labs And Consultants

Environmental monitoring of the parameters involved and the threshold limits

specified are discussed below for the proposed expansion of synthetic organic
chemicals (Bulk drug manufacturing) unit of M/s. Hazelo Lab Pvt. Ltd. The plant
installed remote camera system for the ZLD facility.
5.1.4 Ambient Air Quality (AAQ) Monitoring

Ambient air quality parameters recommended are PM10, PM2.5, Oxides of Nitrogen
(NOX) and Sulphur Dioxide (SO2). These are to be monitored at designated locations
starting from the commencement of construction activity. Data should be generated at
all identified locations in accordance to the National Ambient Air Quality Standards
(Table 5.1) location, duration and the pollution parameters to be monitored and the
responsible institutional arrangements are detailed out in the Environmental
Monitoring Plan.
Table 5.1 National Ambient Air Quality Standards
S.No Pollutant Time Concentration in Ambient Air
Weighted
Industrial, Ecological Methods of
Average
Residential, Sensitive Area Measurement
Rural and (Notified by
Other Area Central
Government)
1 Sulphur Dioxide Annual* 50 20 Improved west and
(SO2) GaekeUltraviolet
24 Hours** 80 80 fluorescence
2 Nitrogen Annual* 40 30 Modified Jacob &
Dioxide (NO2) Hochheiser (Nn-Arsenite)
24 Hours** 80 80 Chemiluminescence
3 Particulate Annual* 60 60 Gravimetic
Matter (Size TOEM
Less than 10 24 Hours** 100 100 Beta Attenuation
µm) or PM10
4 Particulate Annual* 40 40 Gravimetic
Matter (Size TOEM
Less than 24 Hours** 60 60 Beta Attenuation
2.5µm) or PM2.5
5 Ozone (O3) 8 hours** 100 100 UV Photometric
Chemilminescence
1 hour** 180 180 Chemical Method
6 Lead (Pb) Annual* 0.50 0.50 AAS /ICP method after
sampling on EPM 2000 or
24 hours** 1.0 1.0 equivalent filter paper
ED-XRF using Teflon
filter.
7 Carbon 8 hours** 02 02 Non Dispersive Infra Red
Monoxide (CO) (NDIR)

1 hour** 04 04 Spectroscopy
8 Ammonia Annual* 100 100 Chemilminescence
(NH3) 24 hours** 400 400 Indophenol blue method
Gas Chromotography
based continuous
analyzer
9 Benzene (C6H6) Annual* 05 05
Absorption and
Desorption followed by
GC analysis
10 Benzo (o) Annual* 01 01 Solvent extraction
Pyrene(BaP) – followed by HPLC/GC
Particulate analysis
Phase only,
11 Arsenic (As), Annual* 06 06 AAS/ICP method after
equivalent filter paper
12 Nickel (Ni), Annual* 20 20 AAS/ICP method after
equivalent filter paper
*Average Arithmetic mean of minimum 104 measurement in a year taken for a week 24 hourly at
uniform interval.
**24 hourly/8 hourly values should meet 98 percent of the time in a year
5.1.5 Water Quality Monitoring

The physical and chemical parameters recommended for analysis of water quality
relevant are pH, total solids, total dissolved solids, total suspended solids, oil and
grease, COD, chloride, lead, zinc and cadmium. The location, duration and the
pollution parameters to be monitored and the responsible institutional arrangements
are detailed in the Environmental Monitoring Plan. The monitoring of the water quality
is to be carried out at all identified locations in accordance to the Indian Standard
Drinking Water Specification – IS 10500: 1991 (stated in Table 5.2)

Table 5.2 Indian Standard Drinking Water Specifications – IS: 10500:1991

S. No Substance or Requirement Undesirable Effect Outside Methods of Test Remarks
Permis
Absen
Altern
in the
Limit
sible
ce of
Characteristics (Desirable the Desirable Limit (Ref. To IS)
Limit)
ESSENTIAL CHARACTERISTICS
1 Colour, Hazen 5 Above 5, consumer 25 3025 (Part 4)1983 Extended to 25 only if toxic
units, Max. acceptance decreases substances are not suspected,
in absence of alternate sources
2 Odour Unobjectionable - - 3025 (Parts5):1984 a) Test cold and when heated
b) Test at several dilutions
3 Taste Agreeable - - 3025 (Part 7& 8)1984 Test to be conducted only after
safety has been established
4 Turbidity NTU, 5 Above 5, consumer 10 3025 (Part 10)1984 -
Max. acceptance decreases
5 pH Value 6.5 to 8.5 Beyond this range, the water No relaxation 3025 (Part 11)1984 -
will affect the mucous
membrane and/or water
supply system
6 Total hardness (as 300 Encrustation in water 600 3025 (Part 21)1983 -
CaCO3) mg/l, supply structure and
Max adverse effects on domestic
use
7 Iron (as Fe) mg/l, 0.3 Beyond this limit 1 32 of 3025 : 1964 -
Max taste/appearance are
affected, has adverse effect
on domestic uses and water
supply structures, and
promotes iron bacteria
8 Chlorides (as CI) 250 Beyond this limit, taste, 1000 3025 -
mg/l, Max corrosion and palatibility are (Part 32)1988
affected
Team
5-4 Labs And Consultants
Permis
Absen
Altern
in the
Limit
sible
ce of
Limit)
9 Residual, free 0.2 - - 3025 (Part 26)1986 To be applicable only when
chlorine, mg/l, water is chlorinated. Tested at
Min consumer end. When
protection against viral
infection is required, it should
be Min 0.5 mg/l
DESIRABLE CHARACTERISTICS
1 Dissolved solids 500 Beyond this palatability 2000 3025 (Part 16)1984 -
mg/l, Max decreases and may cause
gastro intestinal irritation
2 Calcium (as Ca) 75 Encrustation in water 200 3025 (Part 40)1991 -
mg/l, Max supply structure and
adverse effects on domestic
use
3 Magnesium (as 30 Encrustation to water 100 16, 33, 34 of IS 3025: -
Mg), mg/l, Max supply structure and 1964
adverse effects on domestic
use
4 Copper (as Cu) 0.05 Astringent taste, 1.5 36 of 3025: 1964 -
mg/l, Max discoloration and corrosion
of pipes, fitting and utensils
will be caused beyond this
5 Manganese (as 0.1 Beyond this limit 0.3 35 of 3025: 1964 -
Mn) mg/l, Max taste/appearance are
affected, has adverse effects
on domestic uses and water
supply structures
6 Sulphate (as 200 200 Beyond this causes gastro 400 3025 (Part 24) 1986 May be extended up to 400
SO4) mg/l, Max intestinal irritation when provided (as Mg) does not
Team
Permis
Absen
Altern
in the
Limit
sible
ce of
Limit)
magnesium or sodium are exceed 30
present
7 Nitrate (as NO2) 45 Beyond this, may cause 100 3025 (Part 34) 1988 -
mg/l, Max methaemoglobinemia
8 Fluoride (as F) 1 Fluoride may be kept as low 1.5 23 of 3025: 1964 -
mg/l, Max as possible. High fluoride
may cause fluorosis
9 Phenolic 0.001 Beyond this, it may cause 0.002 54 of 3025: 1964 -
compounds (As objectionable taste and
C6H5OH) mg/l, odour
Max
10 Mercury (as Hg) 0.001 Beyond this, the water No relaxation (see Note) Mercury To be tested when pollution is
mg/l, Max becomes toxic ion analyzer suspected
11 Cadmium (as Cd), 0.01 Beyond this, the water No relaxation (See note) To be tested when pollution is
mg/l, Max becomes toxic suspected
12 Selenium (as Se), 0.01 Beyond this, the water No relaxation 28 of 3025: 1964 To be tested when pollution is
13 Arsenic (As As) 0.05 Beyond this, the water No relaxation 3025 To be tested when pollution is
mg/l, max becomes toxic (Part 37) 1988 suspected
14 Cyanide (As CN), 0.05 Beyond this limit, the water No relaxation 3025 To be tested when pollution is
mg/l, Max becomes toxic (Part 27) 1986 suspected
15 Lead (as Pb), 0.05 Beyond this limit, the water No relaxation (see note) To be tested when pollution is
16 Zinc (As Zn). 5 Beyond this limit it can 15 39 of 3025: 1964) To be tested when pollution is
Mg/l, Max cause astringent taste and an suspected
opalescence in water
17 Anionic 0.2 Beyond this limit it can 1 Methylene-blue To be tested when pollution is
detergents (As cause a light froth in water extraction method suspected
Team
Permis
Absen
Altern
in the
Limit
sible
ce of
Limit)
MBAS) mg/l,
Max
18 Chromium (As 0.05 May be carcinogenic above No relaxation 38 of 3025: 1964 To be tested when pollution is
Cr6+) mg/l, Max this limit suspected
19 Poly nuclear - May be carcinogenic above - - -
aromatic this limit
hydrocarbons (as
PAH) g/1, Max
20 Mineral oil mg/l, 0.01 Beyond this limit un- 0.03 Gas -
Max desirable taste and odour Chromatographic
after chlorination take place method
21 Pesticides mg/l, Absent Toxic 0.001 - -
Max
22 Radioactive materials: 58 of 3025:01964 -
23 a) Alpha emitters - - 0.1 - -
Bq/l, Max
24 Beta emitters - - 1 - -
pci/1, Max
25 Aluminium (as 200 Beyond this limit taste 600 13 of 3025:1964 -
Al), mg/l, Max becomes unpleasant
26 Aluminium (as 0.03 Cumulative effect is 0.2 31 of 3025: 1964 -
Al), mg/l, Max reported to cause dementia
27 Boron, mg/l, Max 1 - 5 29 of 3025: 1964 -
Source: Indian Standard Drinking Water Specification-IS10500:1991
Team
5.1.6 Noise Level Monitoring

The measurements for monitoring noise levels would be carried out at all designated
locations in accordance to the Ambient Noise Standards formulated by Central
Pollution Control Board (CPCB) in 1989 (refer Table 5.3) Sound pressure levels would
be monitored on twenty-four hour basis. Noise should be recorded at a “A” weighted
frequency using a “slow time response mode” of the measuring instrument. The
location, duration and the noise pollution parameters to be monitored and the
responsible institutional arrangements are detailed in the Environmental Monitoring
Plan (Table 5.3)
Table 5.3 Noise level standards (CPCB)
Type Noise level for Day Noise level for
Industrial area 75 70
Commercial area 65 55
Residential area 55 45
Silence zone 50 40
Day time - 6.00 am - 9.00 pm (15 hours)
The monitoring plan along with the environmental parameters and the time frame is
presented in the Table 5.4.
Table 5.4 Environmental Monitoring Plan
(Terms of Reference No. 7 (xii))
S. Particulars Monitoring Standards Duration Important monitoring
No Frequency of parameters
Sampling
Ambient Air Quality Monitoring
1 Industry Quarterly Air (Prevention 24 hrs PM10, PM2.5, SO2, Nox,
Main Gate, Antammagudem and Control of & VOC
Dhotigudem villages Pollution)
2 Work Place Monitoring : Quarterly Rules, CPCB, 8 hr SPM, VOC
Production blocks 6 1994
locations, Solvent Tankfarm,
and ETP area
Stack Emissions Monitoring
1 Utility Stacks : 2 nos. Coal Quarterly Air (Prevention -- PM, SO2, Nox ,
fired boilers, 1 Thermic Fluid and Control of recommended methods
Heater and 3 no.s DG sets. Pollution) of CPCB.
CPCB, 1994
Water Quality Monitoring
1 Process water Daily Water Quality Grab pH, TDS, SS, BOD,
standards by COD and Oil & Grease
CPCB Hardness, , chlorides,
using APHA or BIS
analytical methods.

2 Effluents Stream wise Quarterly Grab pH, TDS, SS, BOD,

COD using APHA or
BIS analytical methods.
3 Treated effluent after ZLD Daily Grab pH, TDS, TSS, COD,
BOD and Oil and
Grease using APHA or
BIS analytical methods.
Noise Quality Monitoring
1 Noise Levels at 3 Locations Quarterly Noise stan- 24 hrs Equivalent Noise levels
with in plant site and 2 dards by CPCB in dB(A)
locations outside the plant
site , Antammagudem
Dhotigudem villages
Soil Quality Monitoring
1 Soil - 3 locations within the Once a year pH, EC, CEC, Lead,
site; storage area, near Moisture, Texture, Bulk
production blocks (6no.s) Density etc.
and ETP area.
5.1.7 Responsibility of Monitoring And Reporting System

The overall responsibility of monitoring the above parameters shall lie with the
management of Hazelo Lab Pvt. Limited. The maintenance/environment wing shall be
responsible for day to day monitoring of effluent, raw water and treated water quality.
The Ambient air quality, Stack emissions, soil, noise and water quality shall be
monitored by either third party or by the Environment management division of the
unit.
Records shall be maintained for the analysis of raw effluents and treated effluents,
ambient air quality data, stack emissions monitoring results, micro- meteorological data
and noise levels. These records are not only required for the perusal of the Pollution
Control Board authorities but also to derive at the efficiencies of the pollution control
equipment as the objective of the project proponent is not only compliance with
statutory regulations, but also a serious commitment towards clean environment.
The industry shall maintain the records as per the hazardous waste regulations and
EPA regulations and apply for the annual consents for air and water, and renewal of
authorization for the storage of hazardous waste as per Hazardous Waste (Handling &
Management) Rules, 1989. The records of hazardous waste manifest will be
maintained.

Reporting system provides the necessary feedback for project management to ensure
quality of the works and that the management plan in implementation. The rationale
for a reporting system is based on accountability to ensure that the measures proposed
as part of the Environmental Management Plan get implemented in the project.
5.1.7.1 Work Zone Monitoring for Hazardous Chemicals

(Terms of Reference No. Sp. TOR (4))
Periodic Workzone monitoring is adopted to review the indoor toxic chemicals

concentration. The periodicity of monitoring is dependent on the concentrations i.e.,
below or above TLV values.
5.2 Environmental Monitoring Budget

The environmental budget for the various environmental management measures in the
EMP is detailed in Table 5.5. There are several other environmental issues that have
been addressed as part of good engineering practices, the costs for which have been
accounted for in the Engineering Costs. Moreover, since environmental enhancements
have not been finalized at this stage, the table projects the typical costs unit wise.
Table 5.5 Environmental Monitoring Budget
Particulars Monitoring Unit Cost Annual Cost
Frequency Rs. Rs.
Ambient Air Quality Monitoring Monthly 4500 162000
Work Place Monitoring Monthly 2000 192000
Stack Emissions Monitoring Monthly 2700 97200
DG Set Stack Emissions Monitoring Quarterly 2700 32400
Process water Daily 500 165000
Effluents - Stream wise Quarterly 600 4800
Treated effluent (ETP water) Daily 600 198000
Noise Level Monitoring Quarterly 1000 20000
Soil Quality Once a year 2000 22000
Total (Rs.) 893400

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HAZELO LAB PVT. LTD.

Declaration by Experts Contributing to the EIA

Name: G.V. Reddy

Signature and Date: November 9, 2016

Period of involvement: October 2015 to till date

Functional area experts:

Team Labs and consultants

4 SE K. Nanaji Site visit, primmary and seecondary data d

Team Labs and

10 RH D. Sadasivudu Site visit, assessment of hazop reports,

Declaration by the Head of the accredited consultant organization/ authorized person

Name: G.V. Reddy

Team Labs and consultants

TEAM Labs and Consultants Mining of minerals including Open

Declaration by Experts Contributing to the EIA

E.0 Executive Summary 1-1

1.0 Introduction of The Project 1-1

Location of the Project:

E-1 Team Labs and consultants

nearest airport is Shamshabad located at a distance of 44 km in southwest direction.

E-2 Team Labs and consultants

24 (2S,3S,5S)-2-Amino-3-Hydroxy-5-Tert-Butylcarbonyl Amino 183388-64-9 0.10

List of By-Products – After Expansion

E-3 Team Labs and consultants

Baseline Environmental Data

E-4 Team Labs and consultants

Identification and Quantification of Impacts

E-5 Team Labs and consultants

Impacts on Socio Economy: There is a potential for direct/indirect employment of about

Environment Management Plan

E-6 Team Labs and consultants

Effluent Treatment System

The High TDS/ COD Effluents

E-7 Team Labs and consultants

The Low TDS/ COD Effluents:

Process emissions contain Ammonia, Carbon dioxide, carbon monoxide, Hydrogen,

E-8 Team Labs and consultants

Solvent Use and Recycle

Occupational Safety and Health

E-9 Team Labs and consultants

Prevention, maintenance and operation of Environment Control Systems

Reduce, Recycle and Reuse

Green Belt Development

E-10 Team Labs and consultants

Post Project Monitoring

Environment Management Department

E-11 Team Labs and consultants

Chemical synthesis produces majority of drugs currently available in the market.

The scientific research and development in API manufacturing is focused on increasing

1-1 Team Labs and consultants

1-2 Team Labs and consultants

1.1 Product Profile (Terms of Reference No. 3(ii) & (iii))

1-3 Team Labs and consultants

Table 1.2 Manufacturing Capacity – After expansion

1-4 Team Labs and consultants

Table 1.3 List of By-Products – After Expansion

1.3 Plant Location & Layout

1-5 Team Labs and consultants

1-6 Team Labs and consultants

1-7 Team Labs and consultants

1.4 Scope of EIA Studies

• An intensive reconnaissance and preliminary collection of environmental

• Field studies to collect preliminary information, particularly on the quality of