1H-Benzimidazole, 5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-, sodium salt;
Sodium (S)-5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}benzimidazolide [161796-78-7]
BRIEFING
Esomeprazole Sodium. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed. The proposal for this drug substance which appeared in PF 47(3) has been canceled and is being replaced with a new proposal.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the XTerra MS C18 brand of column with L1 packing. The typical retention time for omeprazole is about 15 min.
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The liquid chromatographic procedure in the test for Limit of R-Omeprazole was validated using the Chiralpak AGP brand of column with L41 packing. The typical retention time for omeprazole is about 4 min.
Description and solubility information: White to almost white powder. Freely soluble in water and alcohol; soluble in propylene glycol; and practically insoluble in methylene chloride.
(SM3: H. Ramanathan)
Case ID—SUB-1800
USP REFERENCE STANDARDS FOR PURCHASE
USP Esomeprazole Sodium RSUSP Omeprazole RS
USP Omeprazole Related Compound A RS