4-Quinazolinamine, N-[3-chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[[[2-(methylsulfonyl)ethyl]amino]methyl]-2-furanyl]-, 4-methylbenzenesulfonate (1:2);
N-{3-Chloro-4-[(3-fluorobenzyl)oxy]phenyl}-6-{5-[{[2-(methylsulfonyl)ethyl]amino}methyl]furan-2-yl}quinazolin-4-amine bis(4-methylbenzenesulfonate) [388082-77-7]
BRIEFING
Lapatinib Ditosylate. 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 in the Assay was validated using the ZodiacSIL 120 C8-Ace Eps brand of column with L7 packing. The typical retention time for lapatinib is about 8 min.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the ZodiacSIL 120 C8-Ace Eps brand of column with L7 packing. The typical retention time for lapatinib is about 17 min.
Description and solubility information: Yellow colored powder. Freely soluble in dimethylformamide and insoluble in water.
(SM3: M. Jonnada)
Case ID—SUB-1188
USP REFERENCE STANDARDS FOR PURCHASE
USP Lapatinib Ditosylate RSUSP Lapatinib System Suitability Mixture RS