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141354 聚乙烯醇 5-88

EMPROVE® ESSENTIAL Ph Eur,USP,JPE

聚乙烯醇 5-88 MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: PVA, PVOH

CAS #: 9002-89-5 Grade: Ph Eur,USP,JPE
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141354
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Overview

Replacement Information

Key Spec Table

CAS #Grade Value
9002-89-5Ph Eur,USP,JPE

Products

Catalogue NumberPackaging Qty/Pack
1.41354.1000 塑膠瓶 1 kg
1.41354.9029 雙層PE袋 25 kg
Description
Catalogue Number141354
SynonymsPVA, PVOH
References
Product Information
CAS number9002-89-5
GradePh Eur,USP,JPE
HS Code3905 30 00
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Melting Point160 - 240 °C
Bulk density400 - 670 kg/m3
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Rat > 2000 mg/kg
Safety Information according to GHS
RTECSTR8100000
Storage class10 - 13 Other liquids and solids
WGKWGK 1 slightly hazardous to water
Disposal3
Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageStore at +15°C to +25°C.
Packaging Information
Transport Information
Supplemental Information
Specifications
Identity (IR spectrum)passes test
Identity (Viscosity)passes test
Identity (Reaction with iodine)passes test
Identity (Reaction with iodine and boric acid)passes test
Identity (Reaction with ethanol)passes test
Appearance of solution (40 g/l, water)passes test
Appearance of solution (50 g/l, water)passes test
Water-insoluble matter (40 g/l, water)≤ 0.1 %
pH-Value (40 g/l; water)5.0 - 6.5
Viscosity (40 g/l; water)4.3 - 5.7 mPa∙s
As (Arsenic)≤ 2 ppm
Heavy metals (as Pb)≤ 10 ppm
Crotonaldehyde (GC)≤ 10 ppm
Acetic acid (alkalimetric)≤ 0.5 %
Methanol (GC)≤ 1.0 %
Methanol (GC) (JPE)¹≤ 1.0 %
Methyl acetate (GC)≤ 1.0 %
Other residual solvents (ICH Q3C)excluded by production process
Ester value130 - 150
Degree of hydrolysis (USP)85 - 89 %
Degree of hydrolysis (JPE)78 - 96 %
Acid value≤ 3.0
Saponification value132 - 152
Sulfated ash≤ 1.0 %
Loss on Drying (105 °C)≤ 5.0 %
Microbiological purity (Total aerobic microbial count (TAMC))≤ 100 CFU/g
Microbiological purity (Total yeast and mould count (TYMC))≤ 100 CFU/g
Bile-tolerant gram-negative bacteria (absent in 1 g)conforms
Escherichia coli (absent in 1 g)conforms
Pseudomonas aeruginosa (absent in 1 g)conforms
Staphylococcus aureus (absent in 1 g)conforms
Candida albicans (absent in 1 g)conforms
Salmonella (absent in 10 g)conforms
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
¹ Value measured in qualified external laboratory
Corresponds to Ph Eur,USP,JPE
Global Trade Item Number
Catalogue Number GTIN
1.41354.1000 04027269129835
1.41354.9029 04027269129866

Documentation

Material Qualification Dossier

TitleVersion
8.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

聚乙烯醇 5-88 MSDS

Title

Safety Data Sheet (SDS) 

聚乙烯醇 5-88 Certificates of Analysis

Product Number PackagingSpecificationLot Number
1.41354.1000 塑膠瓶PDF Specification Document
1.41354.9029 雙層PE袋PDF Specification Document

Certificates

Title

Technical Info

Title
Use of Polyvinyl Alcohol as an effective Binder in Continuous Twin-Screw Granulation

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Categories

Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Thickeners
Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Surfactants and Stabilizers
Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Surfactants and Stabilizers
Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Thickeners
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Thickeners
Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Binders and Fillers
Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Coatings
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Surfactants and Stabilizers