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141351 Polyvinyl alcohol 8-88

EMPROVE® ESSENTIAL Ph Eur,USP,JPE

Polyvinyl alcohol 8-88 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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141351
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Replacement Information

Key Spec Table

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

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1413511000
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      		 Plastic bottle 1 kg
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      1413519029
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          		 Double PE Sack 25 kg
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          CO1E1413511000
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              CO1E1413519029
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                  Description
                  Catalogue Number141351
                  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)6.8 - 9.2 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
                  1413511000 04027269063719
                  1413519029 04027269074906
                  CO1E1413511000 0
                  CO1E1413519029 0

                  Documentation

                  Material Qualification Dossier

                  TitleVersion
                  4.0

                  Quality Management Dossier (Open Access)

                  Title

                  Operational Excellence Dossier

                  Title

                  Polyvinyl alcohol 8-88 SDS

                  Title

                  Safety Data Sheet (SDS) 

                  Polyvinyl alcohol 8-88 Certificates of Analysis

                  Product Number PackagingSpecificationLot Number
                  1413511000 Plastic bottlePDF Specification Document
                  1413519029 Double PE SackPDF Specification Document
                  CO1E1413511000 PDF Specification Document
                  CO1E1413519029 PDF Specification Document

                  Certificates

                  Title

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                  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