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524950 Vitamin B₁₂ (cyanocobalamin)

EMPROVE® ESSENTIAL Ph Eur,BP,USP

Vitamin B₁₂ (cyanocobalamin) MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: Cyanocobalamin

CAS #: 68-19-9 EC Number: 200-680-0 Molar Mass: 1355.37 g/mol Hill Formula: C₆₃H₈₈Co N₁₄O₁₄P Grade: Ph Eur,BP,USP
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524950
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
68-19-9200-680-0C₆₃H₈₈Co N₁₄O₁₄P1355.37 g/molPh Eur,BP,USP

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      		 Botol kaca 10 g
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      5249500100
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          		 Kaleng metal 100 g
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          Description
          Catalogue Number524950
          SynonymsCyanocobalamin
          References
          Product Information
          CAS number68-19-9
          EC number200-680-0
          GradePh Eur,BP,USP
          Hill FormulaC₆₃H₈₈Co N₁₄O₁₄P
          Molar Mass1355.37 g/mol
          HS Code2936 26 10
          Structure formula ImageStructure formula Image
          Quality LevelMQ500
          Applications
          Biological Information
          Physicochemical Information
          Melting Point>300 °C
          pH value6 (H₂O)
          Bulk density450 - 600 kg/m3
          Solubility12 g/l
          Dimensions
          Materials Information
          Toxicological Information
          Safety Information according to GHS
          RTECSGG3750000
          Storage class10 - 13 Cairan dan padatan lain
          WGKWGK 1 agak berbahaya untuk air
          Safety Information
          Product Usage Statements
          Storage and Shipping Information
          StorageSimpan pada +15°C hingga +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 (photometric, calculated on dried substance)96.0 - 102.0 %
          Identity (Cobalt)passes test
          Identity (HPLC)passes test
          Appearancedark-red, crystalline powder or dark-red crystals
          Absorption ratio (A 361 nm/278 nm)1.70 - 1.90
          Absorption ratio (A 361 nm/550 nm)3.15 - 3.40
          Al (Aluminium)≤ 1 ppm
          Fe (Iron)≤ 130 ppm
          Mn (Manganese)≤ 25 ppm
          Zn (Zinc)≤ 25 ppm
          Related substances (HPLC, Ph Eur) (Impurity A)≤ 0.7 %
          Related substances (HPLC, Ph Eur) (Impurity B)≤ 0.5 %
          Related substances (HPLC, Ph Eur) (Impurity C)≤ 1.5 %
          Related substances (HPLC, Ph Eur) (Impurity D)≤ 0.5 %
          Related substances (HPLC, Ph Eur) (Impurity E)≤ 0.5 %
          Related substances (HPLC, Ph Eur) (Impurity F)≤ 0.5 %
          Related substances (HPLC, Ph Eur) (Each unspecified impurity)≤ 0.2 %
          Related substances (HPLC, Ph Eur) (Sum of all impurities)≤ 3.0 %
          Related substances (HPLC, USP, 7ß,8ß-Lactocyanocobalamin)≤ 1.0 %
          Related substances (HPLC, USP, 50-Carboxycyanocobalamin)≤ 0.5 %
          Related substances (HPLC, USP, 32-Carboxycyanocobalamin)≤ 2.0 %
          Related substances (HPLC, USP, 34-Methylcyanocobalamin)≤ 1.0 %
          Related substances (HPLC, USP, 8-Epi-cyanocobalamin)≤ 1.0 %
          Related substances (HPLC, USP, Any other unidentified impurity)≤ 0.5 %
          Related substances (HPLC, USP, Total impurities)≤ 3.0 %
          Acetone (HS-GC)≤ 5000 ppm
          Other residual solvents (ICH Q3C)excluded by production process
          Loss on Drying (105 °C)
          ≤ 12.0 %
          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
          ≤ 12.0 %
          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
          Corresponds to Ph Eur, BP, USP
          Global Trade Item Number
          Catalogue Number GTIN
          5249500010 04022536261874
          5249500100 04022536261881

          Documentation

          Material Qualification Dossier

          TitleVersion
          10.0

          Quality Management Dossier (Open Access)

          Title

          Operational Excellence Dossier

          Title

          Vitamin B₁₂ (cyanocobalamin) MSDS

          Title

          Safety Data Sheet (SDS) 

          Vitamin B₁₂ (cyanocobalamin) Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          5249500010 Botol kacaPDF Specification Document
          5249500100 Kaleng metalPDF Specification Document

          Certificates

          Title

          Related Products & Applications

          Categories

          Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Ingredients - Liquid
          Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Ingredients - Liquid
          Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Ingredients - Semi Solid
          Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Ingredients-solid
          Biopharmaceutical Manufacturing > Upstream Processing > Cell Culture > Cell Culture Ingredients and Supplements > Cell Culture Ingredients > Vitamins