Butanedioic acid, compd. with 4-amino-5-chloro-2,3-dihydro-N-[1-(3-methoxypropyl)-4-piperidinyl]-7-benzofurancarboxamide (1:1);
4-Amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydro-1-benzofuran-7-carboxamide succinate [179474-85-2]
BRIEFING
Prucalopride Succinate. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is being proposed. The liquid chromatographic procedure in the Assay and the test for Organic Impurities was validated using the XTerra MS C18 brand of column with L1 packing. The typical retention time for prucalopride is about 21 min.
Description and solubility information: White to almost white powder. Freely soluble in water; sparingly soluble in methanol; slightly soluble in N,N-dimethylacetamide.
(SM3: A. Leeks, Jr)
Case ID—SUB-818 and SUB-2770
USP REFERENCE STANDARDS FOR PURCHASE
USP Prucalopride Related Compound A RSUSP Prucalopride Succinate RS