BRIEFING
Bosutinib Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed.
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The liquid chromatographic procedure in the Assay was validated using the Eternity XT C18 brand of column with L1 packing. The typical retention time for bosutinib is about 4 min.
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The test for Dissolution was validated using the Eternity XT C18 brand of column with L1 packing. The typical retention time for bosutinib is about 4 min.
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The liquid chromatographic procedure used in the test for Organic Impurities was validated using the YMC-Triart C18 brand of column with L1 packing. The typical retention time for bosutinib is about 13 min.
This monograph is contingent on FDA approval of a product that meets the proposed monograph requirements.
(SM3: L. Lasker)
Case ID—SUB-1151