ITEMS

SPECIFICATION

RESULTS

Characters

Dark red crystas or amorphous or crystalline red powder

Complies

Identification

A:A_{361 nm}/A_278nm:1.70~1.90

  A_{361 nm}/A_550nm:3.15~3.40

1.87

3.26

B:Cobait:meets USP requirements

Complies

C: HPLC:The retention time of major peak of the sample solution corresponds to that of the standard solution.

Complies

Loss on drying

≤10.0%

1.9%

Assay

97.0%-102.0%

99.0%

Related substances

Total impurities

≤3.0%

0.8%

7β、8β-lactocyanocobalamin

≤1.0%

0.4%

34-methylcyanocobalamin

≤2.0%

＜0.1%

8-Epi-cyanocobalamin

≤1.0%

0.2%

Any other impurity(include

50-carboxycyanocobalamin:32-carboxycyanocobalamin)

≤0.5%

＜0.5%

Acetone

≤5000ppm

27ppm

The total aerobic microbial count

≤1000cfu/g

20cfu

The total Yeasts /Molds count

≤100cfu/g

＜10cfu

Conclusion: Conform to USP40