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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)
The Nippon Synthetic Chemical Industry Co.,Ltd. Basic Products Segment Life Chemical Dept.
Product List (1)
http://www.gohsenol.com
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
GOHSENOLTM EG
Powder Type
Degree of Viscosity *1, *2
Products Hydrolysis (Center value) Main application
[mol%] [mPa・s]
The Nippon Synthetic Chemical Industry Co.,Ltd. Basic Products Segment Life Chemical Dept.
Regulatory Information
http://www.gohsenol.com
The Nippon Synthetic Chemical Industry Co.,Ltd. Basic Products Segment Life Chemical Dept.
Introduction to Application examples
http://www.gohsenol.com
Binder
Granulation Agent API
Excipient
Film Coating Agent
OD Film substrate Binder
The Nippon Synthetic Chemical Industry Co.,Ltd. Basic Products Segment Life Chemical Dept.
Introduction to Application examples
http://www.gohsenol.com
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
The Nippon Synthetic Chemical Industry Co.,Ltd. Basic Products Segment Life Chemical Dept.
Film Properties
http://www.gohsenol.com
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)
The Nippon Synthetic Chemical Industry Co.,Ltd. Basic Products Segment Life Chemical Dept.
Film Properties
http://www.gohsenol.com
The Nippon Synthetic Chemical Industry Co.,Ltd. Basic Products Segment Life Chemical Dept.
Impurities information
http://www.gohsenol.com
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
The Nippon Synthetic Chemical Industry Co.,Ltd. Basic Products Segment Life Chemical Dept.
Impurities information
http://www.gohsenol.com
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
The Nippon Synthetic Chemical Industry Co.,Ltd. Basic Products Segment Life Chemical Dept.
http://www.gohsenol.com
The Nippon Synthetic Chemical Industry Co.,Ltd. Basic Products Segment Life Chemical Dept.