99% Omeprazole USP/CP grade CAS NO.73590-58-6

Product Description


Product name	Omeprazole
Cas number	73590-58-6
Molecular formula	C17H19N3O3S
Molecular weight	345.42
Appearance	White or almost white power
Assay	99%-101.0%
Identification	IR: Same bands as the reference standard
HPLC	The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay
Appearance of Solution	Solution S is clear
Impurities F and G	The solution determined at 440nm is not greater than 0.10
Residue of Solvents( In-house)	Methylene chloride≤100ppm
	Methanol≤3000ppm
	Acetone≤5000ppm
	Triethylamine≤100ppm
Loss on Drying	≤0.2%
Sulphated Ash	≤0.1%
Heavy Metals	≤0.002%
Related Substances (EP)	Impurity D≤0.15%
	Impurity E≤0.15%
	Unspecified impurities≤0.10%
	Total impurities≤0.5%
Chromatographic purity by HPLC (USP)	Any other individual impurity≤0.10%
	Total impurities≤1.0%
Limit of Chloride compound (0671)	≤12.5ppm
Molybdenum test by ICP method	≤10 ppm
Endotoxin	≤8.75 EU/mg
Particle Size	Mean diameter D(4,3)=2-12 µ m
	Upper limit not less than 90%＜28µ m
	Lower limit not more than 15%＜1µ m