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Cianocobalamina 96.0-102.0% (dried basis) Ph. Eur., BP, USP pH 6.0 (1 g/l, H₂O, 20 °C), SAFC®

Fornitore: MERCK PRODUCTION CHEMICALS

5.24950.0250 5.24950.0010 5.24950.0100
5.24950.0250EA 0 EUR
5.24950.0250 5.24950.0010 5.24950.0100
Cianocobalamina 96.0-102.0% (dried basis) Ph. Eur., BP, USP pH 6.0 (1 g/l, H₂O, 20 °C), SAFC®
Cianocobalamina

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 (*).


Certificazioni: Corresponds to Ph Eur, BP, USP

Formula: C₆₃H₈₈CoN₁₄O₁₄P
Peso molecolare: 1355,38 g/mol
Punto di fusione: >300 °C
Temperatura di stoccaggio: Refrigerata
MDL Number: MFCD00151092
CAS Number: 68-19-9
EINECS: 200-680-0
Merck Index: 12,10152

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Risultati del test di specificazione

Assay (Ph Eur, calculated on dried substance) 96.0 - 102.0 %
Assay (USP, calculated on dried substance) 96.0 - 102.0 %
Identity (IR-spectrum) passes test
Identity (Cobalt) passes test
Identity (HPLC) passes test
Appearance dark-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
As (Arsenic) ≤ 3 ppm
Cu (Copper) ≤ 25 ppm
Pb (Lead) ≤ 10 ppm
Zn (Zinc) ≤ 25 ppm
Related substances (HPLC, Ph Eur) ≤ 3 %
Related substances (HPLC, USP, 7ß,8ß-Lactocyanocobalamin) ≤ 1.0 %
Related substances (HPLC, USP, 50-Carboxycyanocobalamin) ≤ 0.5 %
Related substances (HPLC, USP, 34-Methylcyanocobalamin) ≤ 2.0 %
Related substances (HPLC, USP, 32-Carboxycyanocobalamin) ≤ 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 (Ph Eur) ≤ 12.0 %
Loss on drying (USP) ≤ 12.0 %

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