Mecobalamin

Details

Product name:	Mecobalamin
Shelf life	Three years
Inspection Standard:	JP XVI and in house standard
Items	Specifications	Results	Test methods
Characters	Dark red crystals or crystalline powder	Complies	JP Monograph Visual method
Identification	(1) UV: Compare the spectrum with the reference spectrum, Both spectra exhibit similar intensities of absorption at the same wavelengths	Complies	JP Monograph
	(2) Chemical: meets JP requirements	Complies	JP Monograph
Purity (1) Clarity and color of solution	solution is clear and red color	Complies	JP Monograph
(2) Related substances	Each area of the peaks other than mecobalamin is not larger than 0.5% of the peak area of mecobalamin	Complies	JP 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 solvent	Acetone ≤0.5%	0.02%	in house/ ( GC)
Total plate count	≤800 cfu/g	＜10cfu/g	Ch.P.Appendix XI J
Yeasts and Molds	≤80 cfu/g	＜10cfu/g
E.coli	Negative	Complies
Conclusion : The product complies with the specification of JP XVI and in house standard