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141352 Polivinil alkohol 26-88

Overview

Replacement Information

Key Spec Table

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

Pricing & Availability

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1413521000
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      Botol plastik 1 kg
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      1413529029
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          Karung Polietilen ganda 25 kg
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          Description
          Catalogue Number141352
          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 Tikus > 2000 mg/kg
          Safety Information according to GHS
          RTECSTR8100000
          Storage class10 - 13 Cairan dan padatan lain
          WGKWGK 1 agak berbahaya untuk air
          Disposal3
          Reagen organik yang relatif tidak aktif harus dikumpulkan dalam kategori A. Jika terhalogenasi, harus ditempatkan dalam Kategori B. Untuk residu padat gunakan Kategori C.
          Safety Information
          Product Usage Statements
          Storage and Shipping Information
          StorageSimpan pada +15°C hingga +25°C.
          Packaging Information
          Transport Information
          Supplemental Information
          Specifications
          Identity (IR spectrum)conforms
          Identity (Viscosity)conforms
          Identity (wet chemistry)conforms
          Appearance of solution (40 g/l, water)conforms
          Appearance of solution (50 g/l, water)conforms
          Water-insoluble matter (40 g/l, water)≤ 0.1 %
          pH-Value (40 g/l; water)5.0 - 6.5
          Viscosity (40 g/l; water)22.1 - 29.9 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 hydrolysis85 - 89 %
          Acid value≤ 3.0
          Saponification value132 - 152
          Residue on ignition≤ 1.0 %
          Sulfated ash≤ 1.0 %
          Loss on drying (110 °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
          ¹ Value measured in qualified external laboratory
          Corresponds to Ph Eur,USP,JPE
          Global Trade Item Number
          Catalogue Number GTIN
          1413521000 04027269069100
          1413529029 04027269074937

          Documentation

          Material Qualification Dossier

          TitleVersion
          8.0

          Quality Management Dossier (Open Access)

          Title

          Operational Excellence Dossier

          Title

          Polivinil alkohol 26-88 MSDS

          Title

          Safety Data Sheet (SDS) 

          Polivinil alkohol 26-88 Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          1413521000 Botol plastikPDF Specification Document
          1413529029 Karung Polietilen gandaPDF Specification Document

          Certificates

          Title

          Related Products & Applications

          Categories

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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