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108197 Tabletting aid K (cellulose powder)

Overview

Replacement Information

Key Specifications Table

CAS #EC NumberHill FormulaChemical FormulaGrade Value
9004-34-6 232-674-9 (C₆H₁₀O₅)n (C₆H₁₀O₅)n Ph Eur,BP,JP,NF,E 460ii

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1081979020
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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,E 460ii
      Hill Formula(C₆H₁₀O₅)n
      Chemical formula(C₆H₁₀O₅)n
      HS Code3912 90 90
      Quality LevelMQ500
      Applications
      Biological Information
      Physicochemical Information
      Density1.5 g/cm3 (20 °C)
      Flash point260 °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
      Precautionary Statement(s)P260: Do not breathe dust.
      Storage class10 - 13 Other liquids and solids
      WGKNWG not water endangering
      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
      Assay≥ 92 %
      Identitypasses test
      Identity (degree of polymerization)440 - 2250
      Ether-soluble substances≤ 0.15 %
      Water-soluble substances≤ 1.0 %
      Solubilitypasses test
      Suspension testpasses test
      pH-value5.0 - 7.5
      Heavy metals (as Pb)≤ 0.0010 %
      Al (Aluminium)≤ 10 ppm
      As (Arsenic)≤ 3 ppm
      Cd (Cadmium)≤ 1 ppm
      Hg (Mercury)≤ 1 ppm
      Pb (Lead)≤ 1 ppm
      Organic impuritiespasses test
      Residual solvents (ICH Q3C)excluded by production process
      Starch, dextrinpasses test
      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 %
      Particle size (< 5µm)≤ 10 %
      crystallinityNanocrystalline
      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, E 460ii

      Documentation

      Material Qualification Dossier

      Title

      Quality Management Dossier

      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
      1081979020 Plastic drumPDF Specification Document

      Certificates

      Title