1(2H)-Phthalazinone, 4-[[3-[[4-(cyclopropylcarbonyl)-1-piperazinyl]carbonyl]-4-fluorophenyl]methyl]-;
4-[(3-{[4-(Cyclopropylcarbonyl)piperazin-1-yl]carbonyl}-4-fluorophenyl)methyl]phthalazin-1(2H)-one [763113-22-0]
BRIEFING
Olaparib. 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 used in the Assay and the test for Organic Impurities was validated using the XBridge BEH C18 brand of column with L1 packing. The typical retention time for olaparib is about 22 min.
This proposal has undergone the prospective harmonization process with European Pharmacopoeia.
Description and Solubility information: White to pale yellow powder. Soluble in dimethyl sulfoxide and in dimethyl formamide; sparingly soluble in aqueous buffers.
(SM3: R. Fales)
Case ID—SUB-1414