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102094 Calcium gluconate monohydrate

EMPROVE® ESSENTIAL Ph Eur,BP,USP,FCC,E 578

Calcium gluconate monohydrate MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: D-Gluconic acid calcium salt monohydrate

CAS #: 66905-23-5 EC Number: 206-075-8 Molar Mass: 448.38 g/mol Hill Formula: C₁₂H₂₂CaO₁₄ * H₂O Grade: Ph Eur,BP,USP,FCC,E 578
102094
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Overview

Replacement Information

Key Specifications 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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1020941000
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      		 Plastic bottle 1 kg
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      1.02094.9029
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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 LevelMQ500
          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.

          Documentation

          Material Qualification Dossier

          TitleVersion
          2.0

          Quality Management Dossier (Open Access)

          Title

          Calcium gluconate monohydrate SDS

          Title

          Safety Data Sheet (SDS) 

          Calcium gluconate monohydrate Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          1020941000 Plastic bottlePDF Specification Document
          1.02094.9029 Double PE SackPDF Specification Document

          Certificates

          Title
          HALAL Certificate 102094 Calcium gluconate monohydrate EMPROVE® ESSENTIAL Ph Eur,BP,USP,FCC,E 578