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124069 Parteck® TA (Calcium carbonate)

EMPROVE® ESSENTIAL Ph Eur,BP,USP,E 170,FCC

124069
  
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      Overview

      Replacement Information
      Description
      Catalogue Number124069
      References
      Product Information
      CAS number471-34-1
      GradePh Eur,BP,USP,E 170,FCC
      Molar Mass100.09 g/mol
      HS Code2836 50 00
      Quality SegmentMQ500
      Applications
      Biological Information
      Physicochemical Information
      Density2.8 g/cm3
      pH value8.0 (H₂O)
      Dimensions
      Materials Information
      Toxicological Information
      Safety Information according to GHS
      Storage class10 - 13 Other liquids and solids
      WGKNWG not water endangering
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      StorageStore at +2°C to +30°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
      Assay (complexometric; calculated on dried substance)98.5 - 100.5 %
      Identitypasses test
      Substances insoluble in acetic acid≤ 0.2 %
      Substances insoluble in hydrochloric acid≤ 0.2 %
      Chloride (Cl)≤ 0.025 %
      Fluoride (F)≤ 0.0050 %
      Sulfate (SO₄)≤ 0.25 %
      As (Arsenic)≤ 0.0003 %
      Ba (Barium)passes test
      Ba (Barium) (*)≤ 0.0100 %
      Cd (Cadmium) (*)≤ 0.0001
      Co (Cobalt)≤ 0.0001 %
      Cr (Chromium)≤ 0.0100 %
      Cu (Copper)≤ 0.0100 %
      Fe (Iron)≤ 0.0200 %
      Hg (Mercury)≤ 0.00005 %
      Ni (Nickel)≤ 0.0002 %
      Pb (Lead) (*)≤ 0.0003 %
      Sb (Antimony)≤ 0.0100 %
      V (Vanadium) (*)≤ 0.0005
      Zn (Zinc)≤ 0.0100 %
      Magnesium and alkali metals (Ph.Eur.)≤ 1.5 %
      Magnesium and alkali salts (USP)≤ 1.0 %
      Sb, Cu, Cr, Zn, Ba (combination)≤ 0.0100
      Residual solvents (ICH Q3C)excluded by manufacturing process
      Bulk density0.2 - 0.5 g/ml
      Loss on drying (200 °C)≤ 2.0 %
      Particle size (laser diffraction) (d50)2 - 6 µm
      Particle size (laser diffraction) (d90)7 - 15 µm
      Bile tolerant Gram negative Bacteria (absent in 1 g)passes test
      Total aerobic microbial count (TAMC)≤ 500 CFU/g
      Salmonella species (absent in 10g)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 (*).
      Corresponds to Ph Eur, BP, USP, E 170, FCC
      Conforms to the purity criteria on food additives according to the current European Commission Regulation.
      Global Trade ITEM Number
      Catalogue Number GTIN
      124069 0

      Documentation

      Material Qualification Dossier

      TitleVersion
      9.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Parteck® TA (Calcium carbonate) SDS

      Title

      Safety Data Sheet (SDS) 

      Parteck® TA (Calcium carbonate) Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      124069 PDF Specification Document

      Certificates

      Title

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