3-Quinolinecarboxamide, N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxo-;
N-(2,4-Di-tert-butyl-5-hydroxyphenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide [873054-44-5]
BRIEFING
Ivacaftor. 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 procedures in the Assay and the test for Organic Impurities were validated using the ACE C18 brand of column with L1 packing. The typical retention time for ivacaftor in the Assay is about 4 min. The typical retention time for ivacaftor in the Organic Impurities test is about 16 min.
This monograph is contingent on FDA approval of a product that meets the proposed monograph specifications. Please see the Pending Monograph Guideline for additional information.
Description and solubility information: White to off-white powder. Slightly soluble in methanol; practically insoluble in water.
(SM5: Y. Yang)
Case ID—SUB-155
USP REFERENCE STANDARDS FOR PURCHASE
USP Ivacaftor RSUSP Ivacaftor Related Compound A RS
USP Ivacaftor Related Compound B RS