Mecobalamin

Name

Vitamin B12 (Cyanocobalamin)

Test Item

Specification

Appearance

Dark red crystal or crystalline powder, with no smell and no taste; hygroscopicity.

Identification A

A361nm/A278nm:1.70-1.90

A361nm/A550nm:3.15-3.40

Identification B

The retention time of major peak of the sample should be consistent with the standard solution.

Identification C

Positive

Infrared Spectrum

Infrared spectrum of the sample should be consistent with the reforence map

Loss on drying

≤12.0%

Assay

96.0%~102.0%

7β、8β-lactocyanocobalamin

≤1.0%

50-carboxyeyanocobalamin

≤0.5%

34-methylcyanocobalamin

≤2.0%

32-carboxyeyanocobalamin

≤1.0%

8-Epi-cyanocobalamin

≤1.0%

Any other unidentified

≤0.5%

Total impurities

≤3.0%

Total aerobic bacteria count

≤1000cfu/g

Molds、Yeasts

≤100cfu/g

E、coli

Negative

Residual solvents

Acetone≤0.5%

Name

Methylcobalamin(Mecobalamin)

Characters

Dark red crystals or crystalline powder.

Identification

(1)UV : Compare the spectrum with the reference spectrum. Both spectra exhibit similar intensities of absorption at the same
wavelengths.

(2)Cobalt : Meets JP requirement

Clarity and color of solution

The solution is clear and red color

Related substances

Each area of the peaks other than mecobalamin is not more than 0.5% of the peak area of mecobalamin

The total area of the peaks other than mecobalamin is not more than 2.0%

Water

≤11.5%

Assay (Calculated on the anhydrous basis)

98.5%-101.0%

Acetone

≤5000pm

The total aerobic microbial count

≤1000 cfu/g