EG-P For General Information - LC - EG-P - 20151001-002

http://www.gohsenol.
com
GOHSENOLTM EG-P
series
Highly Purified Polyvinyl Alcohol
for
Pharmaceutical Excipients
December 2015
AFC_EG-P_20151001-002
The Nippon Synthetic Chemical Industry Co.,Ltd. Basic Products Segment Life Chemical Dept.
Overview
http://www.gohsenol.com
What is GOHSENOLTM EG ？
“GOHSENOLTM EG” is a highly purified polyvinyl alcohol
(PVA) . All grades comply with major pharmacopoeias.
Chemical Structure
CH2-CH CH2-CH Degree of Polymerization: m + n
m n Degree of Hydrolysis: { m / ( m + n ) } x 100 [mol%]
OH OCOCH3
Pharmacopoeia conformable to
 United States Pharmacopoeia (USP)
 European Pharmacopoeia (EP)
 Japanese Pharmaceutical Excipients (JPE)
Product List (1)
GOHSENOLTM EG
Granule Type
Degree of Viscosity *1, *2
Products Hydrolysis (Center value) Main applications
[mol%] [mPa・s]
EG-03P 3.0-3.8 (3.4) Emulsifier, Wet Granulation Binder
Wet Granulation Binder, Film Coating Agent,
EG-05P 4.6-6.0 (5.3)
Orally Disintegrated Film
EG-18P 15.3-20.7 (18.0) Wet Granulation Binder
86.5-89.0
EG-22P 19.0-25.6 (22.3) Wet Granulation Binder, Thickener for Ophthalmic
EG-30P 25.5-34.5 (30.0) Adhesion Promoter and Dispersion for Gel Patch
EG-40P 36.6-49.4 (43.0) Thickener for Ophthalmic, Microsphere
EG-48P 41.3-55.7 (48.5) Thickener for Ophthalmic
*1. 4% aqueous solution at 20 oC

*2. Indicated as general values. We have several viscosity standard of PVA
fulfilling USP, EP and JPE requirement.
Product List (2)
GOHSENOLTM EG
Powder Type
Degree of Viscosity *1, *2
Products Hydrolysis (Center value) Main application
[mol%] [mPa・s]
Wet Granulation Binder,

EG-05PW 4.6-6.0 (5.3)
Film Coating Agent
Adhesion Promoter and Dispersion for

EG-30PW 86.5-89.0 25.5-34.5 (30.0) Gel Patch,
Thickener for Ophthalmic
Thickener for Ophthalmic,

EG-40PW 36.6-49.4 (43.0)
Emulsifier
*1. 4% water solution at 20 ℃

*2. indicated as general values. We have viscosity standards fulfilling
requirements of USP, EP and JPE.
Regulatory Information
CAS No. 25213-24-5

HS Code. 39053000
JPE*1 Self-Imposed GMP No. GAB 0130001
Drug Master File (Type IV) No.26119
COS/CEP under registration
The following Certificates / Statements available
BSE/TSE Free Radiation Free

Melamine Free Metal Impurities
Gluten Free Allergens statement
GMO Free Residual Solvent
Endotoxins*2 Microbiological test*2
*1 Japanese Pharmaceutical Excipients
*2 Available on request
Introduction to Application examples
Target Area Example (Image)

Solid formulation Pressure,
Tableting
Film Coating
 Binder
 Granulation Agent API
Excipient
 Film Coating Agent
 OD Film substrate Binder
 Suitable for wet granulation binder and film coating agent

 Good adhesion and high binding strength
 Immediate drug release property
 Excellent gas barrier property and better stability
Introduction to Application examples
Target Area Example (Image)

Non-Solid formulation Water Soluble Polymers
Release film
Plaster
(Liner sheet)
 Gel Patch
 Thickener Preparation
 Emulsifier
 Dispersing Agent
Excipient
Base
 High viscosity types can offer good dispersion and adhesive strength
 Suitable for viscosity enhancer and adhesion promoter for Gel Patch
 Excellent surfactant ability is applied for the production of Injectable
microspheres
 Used as thickener in Ophthalmic formulation
Film Properties
Physical properties
GOHSENOLTM EG series excel HPMC and HPC
in film strength and elongation.
＜Comparison between excipients (1)＞
Polyvinyl Hydroxypropyl Hydroxypropyl
Properties*1 Unit Alcohol Methyl Cellulose Cellulose
(PVA)*2 (HPMC)*3 (HPC)*3
Tensile
MPa 40 52 23
strength
Elongation % 130 14 15
Young
MPa 2,283 2,394 945
modulus
*1. Measuring machine: SHIMADZU Autograph AG-IS Film thickness: 30μm Tension rate: 100mm/min,
Casted with 10-20% aqueous solution, Drying at 70oC x 60min, Aged under 23oC x 50%RH x 1 week
*2. PVA: GOHSENOLTM EG-05PW [Viscosity: 5.3 mPa･s (20oC, 4% aqueous solution)]
*3. HPMC: Viscosity: 5 mPa・s, HPC: Viscosity: 6 mPa･s (20oC, 2% aqueous solution)
Film Properties
Gas and water vapor barrier properties

PVA film offers excellent oxygen and water vapor barrier properties.
＜ Comparison between excipients (2)＞
Polyvinyl Hydroxypropyl Hydroxypropyl
Properties Alcohol Cellulose Methyl Cellulose
(PVA)*1 (HPC) (HPMC)
Transmission rate 25℃ 60%RH 0.7 128 152
of O2 gas*2
(cc/m2･day・atm) 40℃ 75%RH 18 > 200 > 200
Transmission rate 25℃ 60%RH 3 95 186
of water vapor*3
(g/m2･day・atm) 40℃ 75%RH 85 470 740
＊１ Grades ： GOHSENOLTM EG-05PW
Film thickness ： 100μm (made by method of Pool cast）
＊２ Measuring machine of transmission of the O2 gas ： OXTRAN2/20
＊３ The method of transmission of water vapor ： Comply with JIS Z 0208
Impurities information
Metal impurities
have been analyzed for 14 metals based on the EMA
guideline.
PVA is far below the detection limit. (N.D.)
EMA Guidelines
Result
Classification Oral Parenteral
(Metal element） Conc. PDE Conc. PDE Conc.
(ppm) [μg/day] (ppm) [μg/day] (ppm)
Class 1A (Pt, Pd) < 0.2 100 10 10 1
Class 1B （Ir, Rh, Ru, Os) < 0.2 100 10 10 1
Class 1C (Mo, Ni, Cr, V) < 0.5 250 25 25 2.5
Class 2 (Cu, Mn) <5 2,500 250 250 25
Class 3 (Fe, Zn) <26 13,000 1,300 1,300 130
Method of Analysis ：Inductively-Coupled Plasma Mass Spectrometer 〔ICP-MS〕
Grades ： GOHSENOLＴＭ EG-05P, EG-48P
Impurities information
Peroxides
Peroxides are contained in the other pharmaceutical
additives, but not detected in Gohsenol.
Grade Result of analysis
<0.1meq *1
EG-05PW
expressed as H2O2 NMT 3.4ppm
*1 Method of Analysis : AOCS (American Oil Chemists’ Society) Cd 8-53
Detection limit : 0.1meq/kg
Reference ( The specification of residual peroxide of PVP in USP 37 ）

Povidon
NMT 400 ppm
（Polyvinyl
expressed as H2O2
pyrrolidone）
Thank you for your attention

The Nippon Synthetic Chemical Industry Co., Ltd.
Life Chemical Dept.
Basic Products Segment
Shibaura Renasite Tower,

9-1, Shibaura 3-chome, Minato-ku, Tokyo,
108-0023, Japan
TEL : +81-3-6436-2813
FAX : +81-3-6436-2820
Sample bottle
Content : 500g

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http://www.gohsenol.

*1. 4% aqueous solution at 20 oC

Wet Granulation Binder,

Adhesion Promoter and Dispersion for

Thickener for Ophthalmic,

*1. 4% water solution at 20 ℃

CAS No. 25213-24-5

BSE/TSE Free Radiation Free

Target Area Example (Image)

 Suitable for wet granulation binder and film coating agent

Target Area Example (Image)

Gas and water vapor barrier properties

Reference ( The specification of residual peroxide of PVP in USP 37 ）

Thank you for your attention

Shibaura Renasite Tower,

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