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108197 Tabletting aid K (cellulose powder)

EMPROVE® ESSENTIAL Ph Eur,BP,JP,NF

Tabletting aid K (cellulose powder) MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
CAS #: 9004-34-6 EC Number: 232-674-9 Chemical Formula: (C₆H₁₀O₅)n Grade: Ph Eur,BP,JP,NF
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108197
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberChemical FormulaGrade Value
9004-34-6232-674-9(C₆H₁₀O₅)nPh Eur,BP,JP,NF

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      		 Plastic drum 20 kg
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      Description
      Catalogue Number108197
      References
      Product Information
      CAS number9004-34-6
      EC number232-674-9
      GradePh Eur,BP,JP,NF
      Chemical formula(C₆H₁₀O₅)n
      HS Code3912 90 90
      Quality LevelMQ500
      Applications
      Biological Information
      Physicochemical Information
      Density1.5 g/cm3 (20 °C)
      Ignition temperature232 °C
      pH value5 - 7.5 (100 g/l, H₂O, 20 °C) (slurry)
      Bulk density70 - 400 kg/m3
      Dimensions
      Materials Information
      Toxicological Information
      LD 50 oralLD50 Rat > 5000 mg/kg
      LD 50 dermalLD50 Rabbit > 2000 mg/kg
      Safety Information according to GHS
      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 (wet chemistry)passes test
      Identity (suspension test)passes test
      Identity (degree of polymerization)440 - 2250
      Ether-soluble substances≤ 0.15 %
      Water-soluble substances≤ 1.5 %
      Solubilitypasses test
      pH-value5.0 - 7.5
      Al (Aluminium)≤ 10 ppm
      Organic impuritiespasses test
      Residual solvents (ICH Q3C)excluded by production process
      Bulk density0.070 - 0.100 g/cm³
      Sulfated ash≤ 0.3 %
      Loss on Drying (105 °C)≤ 6.0 %
      Particle size (> 32 µm)≤ 90 %
      Particle size (> 90 µm)≤ 35 %
      Particle size (> 400 µm)≤ 1 %
      Microbiological purity (Total aerobic microbial count (TAMC))≤ 1E+03 CFU/g
      Microbiological purity (Total yeast and mould count (TYMC))≤ 1E+02 CFU/g
      Bile tolerant Gram negative Bacteria (absent in 1 g)passes test
      Escherichia coli (absent in 1 g)passes test
      Pseudomonas aeruginosa (absent in 1 g)passes test
      Staphylococcus aureus (absent in 1 g)passes test
      Candida albicans (absent in 1 g)passes test
      Salmonella ssp (absent in 10 g)
      passes test
      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 (*).
      Conforms to the purity criteria on food additives according to the current European Commission Regulation.
      Corresponds to Ph Eur, BP, JP, NF
      passes test
      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 (*).
      Conforms to the purity criteria on food additives according to the current European Commission Regulation.
      Corresponds to Ph Eur, BP, JP, NF
      Global Trade Item Number
      Catalogue Number GTIN
      1.08197.9020 04022536101576

      Documentation

      Material Qualification Dossier

      TitleVersion
      9.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Tabletting aid K (cellulose powder) SDS

      Title

      Safety Data Sheet (SDS) 

      Tabletting aid K (cellulose powder) Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1.08197.9020 Plastic drumPDF Specification Document

      Certificates

      Title