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102094 Calcium gluconate monohydrate

Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
66905-23-5206-075-8C₁₂H₂₂CaO₁₄ * H₂O448.38 g/molPh Eur,BP,USP,FCC,E 578

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      Double PE Sack 25 kg
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      Description
      Catalogue Number102094
      SynonymsD-Gluconic acid calcium salt monohydrate
      References
      Product Information
      CAS number66905-23-5
      EC number206-075-8
      GradePh Eur,BP,USP,FCC,E 578
      Hill FormulaC₁₂H₂₂CaO₁₄ * H₂O
      Molar Mass448.38 g/mol
      HS Code2918 16 00
      Structure formula ImageStructure formula Image
      Quality SegmentMQ500
      Applications
      Biological Information
      Physicochemical Information
      Melting Point178 °C
      pH value6.4 - 8.0 (50 g/l, H₂O, 20 °C)
      Bulk density560 kg/m3
      Solubility30 g/l
      Dimensions
      Materials Information
      Toxicological Information
      LD 50 oralLD50 Rat > 5000 mg/kg
      Safety Information according to GHS
      Storage class10 - 13 Other liquids and solids
      WGKWGK 3 highly hazardous to water
      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
      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)98.5 - 102.0 %
      Identity (IR-spectrum)passes test
      Identity (TLC)passes test
      Identity (Calcium)passes test
      Appearancewhite or almost white, crystalline powder
      Appearance of solution (20 g/l, water)passes test
      pH (50 g/l; water)6.0 - 8.0
      Chloride (Cl)≤ 200 ppm
      Oxalate (C₂O₄)≤ 100 ppm
      Phosphate (PO₄)≤ 100 ppm
      Sulfate (SO₄)≤ 100 ppm
      Al (Aluminium)≤ 25 ppm
      As (Arsenic)≤ 3 ppm
      Cu (Copper)≤ 25 ppm
      Fe (Iron)≤ 5 ppm
      Pb (Lead)≤ 2 ppm
      Zn (Zinc)≤ 25 ppm
      Magnesium and alkali metals≤ 0.4 %
      Organic substances and boric acidpasses test
      Residual solvents (ICH Q3C)excluded by manufacturing process
      Reducing substances (USP)≤ 1.0 %
      Sucrose and reducing sugarspasses test
      Loss on drying (105 °C, 16 h)≤ 2.0 %
      Total aerobic microbial count (TAMC)≤ 1000 CFU/g
      Total combined yeasts/moulds count (TYMC)≤ 100 CFU/g
      Bile-tolerant gram-negative bacteria (absent in 1 g)passes test
      Candida albicans (absent in 1 g)passes test
      Escherichia coli (absent in 1 g)passes test
      Pseudomonas aeruginosa (absent in 1 g)passes test
      Salmonella (absent in 10 g)passes test
      Staphylococcus aureus (absent in 1 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 (*).
      This product is not intended for use in preparing injectable dosage forms.
      Corresponds to Ph Eur,BP,USP,FCC,E 578
      Conforms to the purity criteria on food additives according to the current European Commission Regulation.
      Global Trade ITEM Number
      Catalogue Number GTIN
      1020949029 04022536945989