BRIEFING
Olaparib Tablets. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is being proposed.
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The liquid chromatographic procedure used in the Assay and the test for Organic Impurities was validated using the Sunfire C18 brand of column with L1 packing. The typical retention time for olaparib is about 17 min.
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The liquid chromatographic procedure used in the Dissolution test was validated using the Symmetry C18 brand of column with L1 packing. The typical retention time for olaparib is about 3 min.
This proposal has undergone the prospective harmonization process with European Pharmacopoeia.
(SM3: R. Fales)
Case ID—SUB-1456