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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

Pricing & Availability

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1.41353.1000
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      		 Plastic bottle 1 kg
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      1.41353.9029
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          		 Double PE Sack 25 kg
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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
          1.41353.1000 04027269063740
          1.41353.9029 04027269074968

          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
          1.41353.1000 Plastic bottlePDF Specification Document
          1.41353.9029 Double PE SackPDF Specification Document

          Certificates

          Title

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          Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Surfactants and Stabilizers
          Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Thickeners
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          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