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QUALITY CONTROL DEPARTMENT

Certificate of Analysis of Purified Water

Date of Sampling: _________________. A.R.No: ______________________.

Sample Quantity: _________________. Date of Passing: _______________.

Test Observation Limit


Appearance Clear, colourless liquid,
Odourless and tasteless.
Acidity / Alkalinity To comply

Ammonium To comply

Calcium And Magnesium To pure blue colour is


produced.
Heavy Metals NMT 0.1 ppm.

Chloride Appearance of solution does


not change for at least 15
minutes.
Nitrate NMT 0.2 ppm.

Sulphate Appearance of solution does


not change for at least 1 hour.
Oxidisable Substances The solution remains faintly
pink.
Residue On Evaporation NMT 1 mg or 0.001% w/v.

pH 5.0 to7.0

Conductivity NMTs /cm.


Microbial Count Test
A)Total Microbial Count
1)Bacterial Count Not more than 100 cfu/ml.
2)Fungal Count Not more than 10 cfu/ml.
B) Microbial Limit Test
1)E-Coli Absent
2)Salmonella Absent

Remark: The Above Water Sample Complies/ Does Not Comply As Per IP Specification .

Analyst: Approved Chemist:


Residue on Evaporation: (Lt. NMT 0.001% w/v)
i) Weight of empty evaporating dish =----------------------- gm
100 ml of Sample taken for test, after Evaporation ,

ii) Weight of evaporating dish + residue =----------------------- gm

iii) Weight of residue =----------------------- gm

% Residue = _________________ x 100 =----------------------- %


100

Analyst: Approved Chemist:


Observation/ Calculation sheet:
1. Acidity or Alkalinity:
a) 10 ml of Sample, boiled & cooled + 0.05 ml of Methyl red solution. Since solution _____________________
Complies/ Does not Comply
b) 10 ml of Sample + 0.1 ml of Bromo thymol blue solution. Since solution is ____________________________
Complies/ Does not Comply
2. Ammonium:
Sample: 20 ml sample + 1 ml of alkaline potassium mercuric- iodide solution.
Standard: 2.5 ml dilute ammonium chloride solution + 1 ml alkaline potassium mercuric-iodide solution
+ 7.5 ml sample
Standard color________________________________ sample color. Complies/ Does not Comply
3. Calcium and Magnesium:
Sample: 100 ml sample + 2 ml of ammonium buffer pH 10.0 + 50 mg of mordant black II + 0.5 ml of
disodium edetate
Observation_______________________________________________ Complies/ Does not Comply
4. Heavy Metals: (Lt. NMT 0.1 ppm)
Sample: 150 ml evaporate to 15 ml/ 2 ml used for tests.
Standard: 10 ml of standard lead solution (1ppm/ ml) + 2 ml of test solution
Standard color________________________________ sample color. Complies/ Does not Comply
5. Chloride:
Sample: 10 ml sample + 1 ml of 2 M HNO3 + 0.2 ml of 0.1 M AgNO3
Observation: Color of solution change/ does not change within 15 mints.
Complies/ Does not Comply
6. Nitrate: (Lt. NMT 0.2 ppm)
Sample: 5 ml sample + 0.4 ml of 10% w/v KCl solution + 0.1 ml of diphenylamine + 5 ml of sulphuric
acid
Standard: 0.5 ml of nitrate standard solution (2ppm NO3 ) + 4.5 ml of water (stand for 15 mints at
50°C) Standard color________________________________ sample color.
Complies/ Does not Comply
7. Sulphate:
Sample: 10 ml sample + 0.1 ml of 2M HCl + 0.1 ml of barium chloride solution.
Observation: The appearance of the solution change/ does not change within 1 hour.
Complies/ Does not Comply
8. Oxidisable substance:
Sample: 100 ml of sample + 10 ml of sulphuric acid + 0.1 ml of 0.02 M potassium permanganate; boil.
Observation: _________________________________________________.
Complies/ Does not Comply
9. Residue on Evaporation: (Lt. NMT 0.001% w/v)
i) Weight of empty evaporating dish =----------------------- gm
100 ml of Sample taken for test, after Evaporation ,
ii) Weight of evaporating dish + residue =----------------------- gm
iii) Weight of residue =----------------------- gm
% Residue = _________________ x 100 =----------------------- %
100
Analyst: Approved Chemist:
Date:-

To,
Q.C. DEPARTMENT
Subject: Requisition for DM water

Sir,
Please collect the sample of D.M. Water for analysis purpose and give testing report as early as
posible.

Regards
Production Department

Date:-

To,
Q.C. DEPARTMENT
Subject: Requisition for DM water

Sir,
Please collect the sample of D.M. Water for analysis purpose and give testing report as early as
posible.

Regards
Production Department
MICROBIOLOGICAL ANALYSIS OF PURIFIED WATER

Department : Quality Control (Microbiology) Sampled By :

Point No. : Report No. :


Qty. sampled: Date of Analysis :
Date of Sampling: Date of Report :

REPORT OF ANALYSIS

Tests Result of Analysis Limits


MICROBIAL LIMIT TEST
1. Total Viable Count
a) Total Bacterial Count TBC) Action Limit-100 cfu/ml
Alert Limit-70 cfu/ml
c) Total Fungal Count (TFC)
Action Limit-10 cfu/ml
Alert Limit-7 cfu/ml
2. Pathogen Testing
a)Eschericha coli Absent
b) salmonella Absent
c) Pseudomans aeruginosa Absent
d) Staphylocococcus aureus Absent

]
REMARK: In the opinion of undersigned the above sample complies / does not complies with the specification
prescribed unde IP/BP/USP/ In House specification.

Tested By: Checked by : Approved By: