Amisulpride
C17H27N3O4S
369.48
Benzamide, 4-amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]-5-(ethylsulfonyl)-2-methoxy-;
4-Amino-N-[(1-ethylpyrrolidin-2-yl)methyl]-5-(ethylsulfonyl)-2-methoxybenzamide [71675-85-9]
Benzamide, 4-amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]-5-(ethylsulfonyl)-2-methoxy-;
4-Amino-N-[(1-ethylpyrrolidin-2-yl)methyl]-5-(ethylsulfonyl)-2-methoxybenzamide [71675-85-9]
BRIEFING
Amisulpride. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed.
The liquid chromatographic procedure in the Organic Impurities test was validated using the Zorbax Rx-C8 brand of column with L7 packing. The typical retention time for amisulpride is about 17 min.
Description and Solubility information: White or almost white crystalline powder. Freely soluble in methylene chloride; sparingly soluble in anhydrous ethanol; and practically insoluble in water.
(SM3: M. Jonnada)
Case ID—SUB-397
USP REFERENCE STANDARDS FOR PURCHASE
USP Amisulpride RSUSP Amisulpride Related Compound A RS
USP Amisulpride System Suitability Mixture RS