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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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5249500010
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      		 Glass bottle 10 g
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      5249500100
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          		 Metal can 100 g
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          5249500250
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              		 Plastic bottle 250 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 Other liquids and solids
              WGKWGK 1 slightly hazardous to water
              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 (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
              5249500250 04022536261898

              Documentation

              Material Qualification Dossier

              TitleVersion
              10.0

              Quality Management Dossier (Open Access)

              Title

              Operational Excellence Dossier

              Title

              Required Licenses

              Title
              CARTA DE USO GENERAL 2016
              PRODUCTO REGULADO POR LA SECRETARÍA DE SALUD

              Vitamin B₁₂ (cyanocobalamin) SDS

              Title

              Safety Data Sheet (SDS) 

              Vitamin B₁₂ (cyanocobalamin) Certificates of Analysis

              Product Number PackagingSpecificationLot Number
              5249500010 Glass bottlePDF Specification Document
              5249500100 Metal canPDF Specification Document
              5249500250 Plastic bottlePDF Specification Document

              Certificates

              Title

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