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524950 Vitamín B₁₂ (kyanokobalamín)

Overview

Replacement Information

Key Spec Table

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

Products

Catalogue NumberPackaging Qty/Pack
5249500010 Sklená flaša 10 g
5249500100 Kovová nádoba 100 g
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 Iné kvapaliny a tuhé látky
WGKWGK 1 mierne ohrozujúce vody
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageSkladujte pri +15°C až +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

Vitamín B₁₂ (kyanokobalamín) MSDS

Title

Safety Data Sheet (SDS) 

Vitamín B₁₂ (kyanokobalamín) Certificates of Analysis

Product Number PackagingSpecificationLot Number
5249500010 Sklená flašaPDF Specification Document
5249500100 Kovová nádobaPDF 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