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141350 Polyvinyl alcohol 4-88

EMPROVE® ESSENTIAL Ph Eur,ChP,USP,JPE

Polyvinyl alcohol 4-88 MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: PVA, PVOH

CAS #: 9002-89-5 Hill Formula: (C₂H₄O)n Grade: Ph Eur,ChP,USP,JPE
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141350
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Overview

Replacement Information

Key Spec Table

CAS #Hill FormulaGrade Value
9002-89-5(C₂H₄O)nPh Eur,ChP,USP,JPE

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1413501000
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      		 Plastic bottle 1 kg
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      1413509029
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          		 Double PE Sack 25 kg
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          CO1E1413501000
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              Description
              Catalogue Number141350
              SynonymsPVA, PVOH
              References
              Product Information
              CAS number9002-89-5
              GradePh Eur,ChP,USP,JPE
              Hill Formula(C₂H₄O)n
              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)3.4 - 4.6 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, ChP)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
              1413501000 04027269063689
              1413509029 04027269074876
              CO1E1413501000 04061839802254

              Documentation

              Material Qualification Dossier

              TitleVersion
              10.0

              Quality Management Dossier (Open Access)

              Title

              Operational Excellence Dossier

              Title

              Polyvinyl alcohol 4-88 SDS

              Title

              Safety Data Sheet (SDS) 

              Polyvinyl alcohol 4-88 Certificates of Analysis

              Product Number PackagingSpecificationLot Number
              1413501000 Plastic bottlePDF Specification Document
              1413509029 Double PE SackPDF Specification Document
              CO1E1413501000 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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              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