Cyanocobalamin USP/EP Vitamins made in china CAS NO.68-19-9

characteristics

dark-red crystalline powder or crystals

solubility

sparingly soluble in water and ethanol(96%),practically insoluble in acetone.

identification

ratio of optical density

a361/a550nm: 3.15~3.40

a361/a278nm: 1.7~1.88

tlc: conforms

chemical:positive

hplc：the retention time of major peak of the sample solution corresponds to that of the standard solution

pseudo cyanocobalamin

usp(separator)

related substances

total impurities

≤3.0%

single impurity

7β，8β-lactocyanocobalamin≤1.0%

50-carboxycyanocobalamin≤0.5%

34-methylcyanocobalamin≤2.0%

32-carboxycyanocobalamin≤1.0%

8-epi-cyanocobalamin≤1.0%

any other unidentified impurity≤0.5%

loss on drying

≤12.0%

assay on dried basis

96.0%~102.0%

residual solvents

acetone: ≤ 1000ppm

ethanol: ≤ 1000ppm

total plate count(cfu/g)

≤ 100

yeast and mould(cfu/g)

≤10

enterobacteriae

negative

staphylococcus aureus

negative

pseudomonas aeruginosa

negative

endotoxin

＜0.35eu/µg