Customization: | Available |
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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 |
||||
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. |