Mecobalamin

CAS number: 13422-55-4

Molecular formula: C63H91CoN13O14P

molecular weight: 1344.3823

Chemical structure:

Product name:    Mecobalamin
Shelf lifeThree years
Inspection Standard: JP XVI and in house standard
ItemsSpecificationsResultsTest methods
CharactersDark red crystals or crystalline powderCompliesJP Monograph Visual method
Identification(1) UV: Compare the spectrum with the reference spectrum, Both spectra exhibit similar intensities of absorption at the same wavelengthsCompliesJP Monograph
(2) Chemical: meets JP requirementsCompliesJP Monograph

Purity


(1) Clarity and color of solution


solution is clear and red color



Complies



JP Monograph

(2) Related substancesEach area of the peaks other than mecobalamin is not larger than 0.5% of the peak area of mecobalaminCompliesJP Monograph/JP <2.01>
The total area of the peaks other than mecobalamin is not larger than 2.0%0.69%
Water≤11.5%4.72%JP Monograph/ JP <2.48>
Assay≥98.5%99.6%JP Monograph
Residual solventAcetone ≤0.5%0.02%in house/ ( GC)
Total plate count≤800 cfu/g<10cfu/gCh.P.Appendix XI J
Yeasts and Molds≤80 cfu/g<10cfu/g
E.coliNegative Complies
Conclusion : The product complies with the specification of JP XVI and in house standard