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141353 Polyvinyl alcohol 40-88

EMPROVE® ESSENTIAL Ph Eur,ChP,USP,JPE

Polyvinyl alcohol 40-88 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,ChP,USP,JPE
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141353
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Overview

Replacement Information

Key Spec Table

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

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      Description
      Catalogue Number141353
      SynonymsPVA, PVOH
      References
      Product Information
      CAS number9002-89-5
      GradePh Eur,ChP,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)34.0 - 46.0 mPa∙s
      As (Arsenic)≤ 2 ppm
      As (Arsenic) (ChP)≤ 2 ppm
      Heavy metals (as Pb)≤ 10 ppm
      Heavy metals (as Pb) (ChP)≤ 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
      Residue on ignition≤ 1.0 %
      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,ChP,USP,JPE
      Global Trade Item Number
      Catalogue Number GTIN
      1413531000 04027269063740

      Documentation

      Material Qualification Dossier

      TitleVersion
      9.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Polyvinyl alcohol 40-88 SDS

      Title

      Safety Data Sheet (SDS) 

      Polyvinyl alcohol 40-88 Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1413531000 Plastic bottlePDF Specification Document

      Certificates

      Title

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      Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Surfactants and Stabilizers