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Specification Test Results
- 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 %
Specification Test Results
Supplier: VWR International
Supplier: VWR International
Supplier: VWR International
Supplier: VWR International
Supplier: VWR International
Supplier: VWR International
Supplier: VWR International
Supplier: VWR International
Supplier: VWR International
Supplier: Ansell Healthcare
Supplier: Janitorial Supplies
Supplier: Kimberly-Clark