Butanedioic acid, hydroxy-, (2S)-, compound with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1);
N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide hydrogen (2S)-2-hydroxybutanedioate [341031-54-7]
BRIEFING
Sunitinib Malate. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed. The proposal for this drug substance which appeared in PF 46(4) [Jul.– Aug. 2020] was canceled and is replaced with a new proposal.
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The liquid chromatographic procedure in the Assay is based on analyses performed with the XBridge Shield RP18 brand of column with L1 packing. The typical retention time for sunitinib is about 11 min.
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The liquid chromatographic procedure in the test for Organic Impurities is based on analyses performed with the XBridge Shield RP18 brand of column with L1 packing. The typical retention time for sunitinib is about 41 min.
(SM3: S. Ramakrishna)
Correspondence Number—C199050; C315839; C319588