| Product name | Cyanocobalamin (Vitamin B12) | Country of origin | China | |
| Retest-life | 5Years | |||
| According as | Ph.Eur. 10.3 and in house standard | |||
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Test items
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Specifications |
Test methods
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Characters
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Dark red ,crystalline powder or dark red crystals | Ph.Eur.monograph:0547 Visual method | ||
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Identification A |
UV:Absorption maxima at 278nm,361nm and 547-559nm. |
Ph.Eur. monograph/Ph.Eur.<2.2.25> |
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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> |
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| Loss on drying | ≤10.0% |
Ph.Eur.
monograph/Ph.Eur.<2.2.32> |
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Assay
|
97.0%~102.0% |
Ph.Eur.
monograph/Ph.Eur.<2.2.25> |
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Related substances |
Total impurities≤3.0% |
Ph.Eur. monograph / Ph.Eur. <2.2.29> (UHPLC) |
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| 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% | ||||
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A cetone
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≤5000ppm |
In house (GC)
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The total aerobic
microbial count |
≤1000 cfu/g |
ChP 2023 <1105>
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The total combined
yeasts/mould count |
≤100 cfu/g |
ChP 2023 <1105>
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Conclusion : The product complies with the specification of Ph.Eur. 10.3 and in house standard
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| 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 |
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A361 nm/A278nm : 1.70~1.90
A361 nm/A550nm : 3.15~3.40 |
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IdentificationB
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Cobalt: Meets USP requirements
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USP monograph
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IdentificationC
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HPLC:The retention time of the major peak of the sample solution corresponds to that of the standard solution. |
USP monograph
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Loss on drying
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≤10.0% | USP monograph/USP<731> |
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Assay
|
97.0%~102.0% |
USP monograph
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|
Related substances |
Total impurities ≤3.0 % |
USP monograph |
| 7β,8β-Lactocyanocobalamin ≤ 1.0 % | ||
| 34-Methylcyanocobalamin ≤2.0 % | ||
| 8-Epi-cyanocobalamin ≤1.0 % | ||
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Any other impurity
(Include 50-Carboxycyanocobalamin; 32- Carboxycyanocobalamin)≤0.5% |
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| A cetone | ≤5000ppm | In house/(GC) |
| The total aerobic microbial count | ≤1000 cfu/g |
ChP <1105>
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The total combined
yeasts/mould count |
≤100 cfu/g |
ChP <1105>
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Conclusion : The product complies with the specification of USP 43 and in house standard.
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