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
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 |
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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