| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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| Product name | Cyanocobalamin (Vitamin B12) | Country of origin | China | |
| Retest-life | 5Years | |||
| According as | Ph.Eur. 10.3 and in house standard | |||
| Test items |
Specifications | Test methods |
||
| Characters |
Dark red ,crystalline powder or dark red crystals | Ph.Eur.monograph:0547 Visual method | ||
Identification A |
UV:Absorption maxima at 278nm,361nm and 547-559nm. | Ph.Eur. monograph/Ph.Eur.<2.2.25> |
||
| A361nm/A278nm : 1.70~1.90 A361nm/A547-559nm :3.15~3.45 |
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Identification B |
UHPLC:The principal peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution(c). | Ph.Eur. monograph/Ph.Eur.<2.2.29> |
||
| Loss on drying | ≤10.0% | Ph.Eur. monograph/Ph.Eur.<2.2.32> |
||
| Assay |
97.0%~102.0% | Ph.Eur. monograph/Ph.Eur.<2.2.25> |
||
Related substances |
Total impurities≤3.0% | Ph.Eur. monograph / Ph.Eur. <2.2.29> (UHPLC) |
||
| 7β,8β-Lactone-cyanocobalamin≤0.7% | ||||
| 50-Carboxycyanocobalamin≤0.5 % | ||||
| 34-Methylcyanocobalamin≤1.5% | ||||
| 32-Carboxycyanocobalamin≤0.5 % | ||||
| 8-Epi-cyanocobalamin≤0.5% | ||||
| Impurity F ≤0.5% | ||||
| Unspecified impurities≤0.2% | ||||
| A cetone |
≤5000ppm | In house (GC) |
||
| The total aerobic microbial count |
≤1000 cfu/g | ChP 2020 <1105> |
||
| The total combined yeasts/mould count |
≤100 cfu/g | ChP 2020 <1105> |
||
| Conclusion : The product complies with the specification of Ph.Eur. 10.3 and in house standard |
||||
| Product name | Cyanocobalamin(Vitamin B12) | |
| Country of origin | China | |
| Retest-life | 5Years | |
| According as | USP 43 and in house standard | |
| Test items | Specifications | Test methods |
| Characters | Dark red crystals or amorphous or crystalline red powder. | Visual method |
Identification A |
UV: The absorption spectrum exhibits maxima at 278±1nm,361±1nm,and550±2nm . | USP monograph |
| A361 nm/A278nm : 1.70~1.90 A361 nm/A550nm : 3.15~3.40 |
||
| IdentificationB |
Cobalt: Meets USP requirements |
USP monograph |
| IdentificationC |
HPLC:The retention time of the major peak of the sample solution corresponds to that of the standard solution. | USP monograph |
| Loss on drying |
≤10.0% | USP monograph/USP<731> |
| Assay |
97.0%~102.0% | USP monograph |
Related substances |
Total impurities ≤3.0 % | USP monograph |
| 7β,8β-Lactocyanocobalamin ≤ 1.0 % | ||
| 34-Methylcyanocobalamin ≤2.0 % | ||
| 8-Epi-cyanocobalamin ≤1.0 % | ||
| Any other impurity (Include 50-Carboxycyanocobalamin; 32- Carboxycyanocobalamin)≤0.5% |
||
| A cetone | ≤5000ppm | In house/(GC) |
| The total aerobic microbial count | ≤1000 cfu/g | ChP <1105> |
| The total combined yeasts/mould count |
≤100 cfu/g | ChP <1105> |
| Conclusion : The product complies with the specification of USP 43 and in house standard. |
||
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