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124069 Parteck® TA (Calcium carbonate)

Overview

Replacement Information

Key Spec Table

CAS #Molar MassGrade Value
471-34-1100.09 g/molPh Eur,BP,USP,E 170,FCC

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1240691000
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      Plastic bottle 1 kg
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      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 LevelMQ500
      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
      1240691000 04065269062516

      Documentation

      Material Qualification Dossier

      TitleVersion
      7.0

      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
      1240691000 Plastic bottlePDF Specification Document

      Certificates

      Title