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141354 Polyvinyl alcohol 5-88

Overview

Replacement Information

Key Spec Table

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

Pricing & Availability

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1413541000
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      1413549029
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          Double PE Sack 25 kg
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          CO1E1413541000
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                      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
                      1413541000 04027269129835
                      1413549029 04027269129866
                      CO1E1413541000 04061839802285
                      CO1E1413549029 04061839802292
                      CO1I1413541000 0

                      Documentation

                      Material Qualification Dossier

                      TitleVersion
                      8.0

                      Quality Management Dossier (Open Access)

                      Title

                      Operational Excellence Dossier

                      Title

                      Polyvinyl alcohol 5-88 SDS

                      Title

                      Safety Data Sheet (SDS) 

                      Polyvinyl alcohol 5-88 Certificates of Analysis

                      Product Number PackagingSpecificationLot Number
                      1413541000 Plastic bottlePDF Specification Document
                      1413549029 Double PE SackPDF Specification Document
                      CO1E1413541000 PDF Specification Document
                      CO1E1413549029 PDF Specification Document
                      CO1I1413541000 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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                      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