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108197 Excipient K pentru pastilare (pudra celulozica)

EMPROVE® ESSENTIAL Ph Eur,BP,JP,NF

Excipient K pentru pastilare (pudra celulozica) 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

Pricing & Availability

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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
      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) (barbotină)
      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 Alte lichide sau solide
      WGKWGK 1 slabă contaminare a apei
      Disposal3
      Reactivii organici relativ cu reactivitate relativ redusa trebuie colectati in containerul A. Daca sunt halogenati, ei trebuie colectati in containerul B. Pentru reziduurile solide utilizati containerul C.
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      StorageA se depozita între +15°C la +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
      1081979020 04022536101576

      Documentation

      Emprove Dossier

      TitleVersion
      9.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Excipient K pentru pastilare (pudra celulozica) MSDS

      Title

      Safety Data Sheet (SDS) 

      Excipient K pentru pastilare (pudra celulozica) Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1081979020 Plastic drumPDF Specification Document

      Certificates

      Title