Item
|
Standard
|
Result
|
|
Red crystal or crystalline hygroscopic powder, with no smell and no taste; Hygroscopicity.
|
Complies
|
|
A361nm/A278nm:1.70-1.90
|
1.83
|
A361nm/A550nm:3.15-3.40
|
3.25
|
|
The retention time of major peak of the sample solution corresponds to that of the standard solution.
|
|
Infrared spectrum
|
The infrared spectrum of the sample should be consistent with the reference map.
|
Complies
|
Identification C
|
Positive
|
Complies
|
Loss on drying
|
≤12.0%
|
2.2%
|
Assay on dried basis
|
96.0%-102.0%
|
99.0%
|
Total impurities
|
≤3.0%
|
1.24%
|
7β,8β-lactocyanocobalamin
|
≤1.0%
|
0.24%
|
50-carboxycyanocobalamin
|
≤0.5%
|
0.08%
|
34-methylcyanocobalamin
|
≤2.0%
|
Not detected
|
32-carboxycyanocobalamin
|
≤1.0%
|
0.31%
|
8-Epi-cyanocobalamin
|
≤1.0%
|
0.22%
|
Other unidentified impurity
|
≤0.5
|
0.13%
|
Total aerobic bacteria count
|
≤1000cfu/g
|
20cfu/g
|
Mould & yeasts
|
≤100cfu/g
|
Not detected
|
E.Coli
|
Negative
|
Not detected
|
Endotoxin
|
≤0.4EU/mg
|
Complies
|
Residual solvents
|
Acetone≤0.5%
|
0.072%
|