Vitamin B12 (Methylcobalamin)
Città: LV, Marupe
Physical & Chemical Characteristics
Analysis Item | Specification | Result |
Characters | Dark red crystals or crystalline powder | Complies |
Identification (1) | UV: Compare the spectrum with reference — both spectra exhibit similar intensities at same wavelengths | Complies |
Identification (2) | Cobalt: requirement | Complies |
Color of Solution | The solution is clear and red color | Complies |
Size | (≤250um) ≥90>#/span### | Complies* |
Impurities
Analysis Item | Specification | Result |
Any impurity (single) | ≤0.5% | 0.5% |
Total impurities | ≤2.0% | 1.3% |
Water | ≤11.5% | ≤5.6% |
Other Tests
Analysis Item | Specification | Result |
Loss on Drying | ≤11.5% | <11.5% |
Residual Solvent (Acetone) | ≤0.5% | 0.07% |
Assay (on the anhydrous basis) | 98.5%-101.0% | 99.0% |
Acetone | ≤5000ppm | 180ppm |
Microbiological Tests
Analysis Item | Specification | Result |
Total Plate Count | ≤1000 CFU/g | 15 CFU/g |
Total combined yeasts/mould count | ≤100 CFU/g | 10CFU/g |
E. coli | Absence (/10g) | Complies* |
Salmonella | Absence (/10g) | Complies* |
Staphylococcus aureus | Absence (/g) | Complies* |
Bile-Tolerant Gram-Negative Bacteria | Absence (/g) | Complies* |
Heavy Metals
Analysis Item | Specification | Result |
Lead (Pb) | ≤0.5 ppm | Complies* |
Arsenic (As) | ≤1.0 ppm | Complies* |
Cadmium (Cd) | ≤1.0 ppm | Complies* |
Mercury (Hg) | ≤0.1 ppm | Complies* |