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105006 Bole white

powder low bacterial content, for internal use EMPROVE® ESSENTIAL Ph Eur,BP

Bole white MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
CAS #: 1332-58-7 EC Number: 310-194-1 Grade: Ph Eur,BP
105006
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Overview

Replacement Information

Key Specifications Table

CAS #EC NumberGrade Value
1332-58-7310-194-1Ph Eur,BP

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1050069025
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      		 Fibre carton 25 kg
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      Description
      Catalogue Number105006
      References
      Product Information
      CAS number1332-58-7
      EC number310-194-1
      GradePh Eur,BP
      HS Code2507 00 20
      Quality LevelMQ500
      Applications
      Biological Information
      Physicochemical Information
      Density2.6 g/cm3 (20 °C)
      pH value6 - 7 (50 g/l, H₂O, 20 °C) (slurry)
      Bulk density470 kg/m3
      Dimensions
      Materials Information
      Toxicological Information
      Safety Information according to GHS
      RTECSGF1670500
      Storage class10 - 13 Other liquids and solids
      WGKNWG not water endangering
      Disposal14
      Inorganic salts: Container I. Neutral solutions of the these salts: Container D. Before placing in Container D, check the pH with pH-Universal indicator strips (Item No. 109535).
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      StorageStore at +2°C to +25°C.
      Packaging Information
      Transport Information
      Declaration (railroad and road) ADR, RIDKein Gefahrgut
      Declaration (transport by air) IATA-DGRNo Dangerous Good
      Declaration (transport by sea) IMDG-CodeNo Dangerous Good
      Supplemental Information
      Specifications
      Identitypasses test
      Substances soluble in hydrochloric acid≤ 1 %
      Acidic or alkaline impuritiespasses test
      Chloride (Cl)≤ 250 ppm
      Sulfate (SO₄)≤ 1000 ppm
      As (Arsenic)*≤ 1.5 ppm
      Ba (Barium)*≤ 140 ppm
      Ca (Calcium)≤ 250 ppm
      Co (Cobalt)*≤ 5 ppm
      Mn (Manganese)≤ 25 ppm
      Pb (Lead)*≤ 10 ppm
      V (Vanadium)*≤ 10 ppm
      Organic impuritiespasses test
      Adsorption powerpasses test
      Residual solvents (ICH Q3C)excluded by production process
      Loss on ignition (600 °C)≤ 15 %
      Lumpspasses test
      Microbiological purity (Total aerobic microbial count (TAMC))≤ 1000 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 ssp (absent in 10 g)conforms
      Swelling powerpasses test
      Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental impurities). The values refer to the extract (Extraction agent: Nitric acid 65%). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
      Not for food use.
      Corresponds to Ph Eur, BP

      Documentation

      Material Qualification Dossier

      TitleVersion
      2.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Bole white SDS

      Title

      Safety Data Sheet (SDS) 

      Bole white Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1050069025 Fibre cartonPDF Specification Document

      Certificates

      Title