BRIEFING

 Lapatinib Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is being proposed.

1. The liquid chromatographic procedure in the Assay was validated using the XTerra RP18 brand of column with L1 packing. The typical retention time for lapatinib is 4 min.

2. The test for Dissolution was validated using the XTerra RP18 brand of column with L1 packing. The typical retention time for lapatinib is about 4 min.

3. The liquid chromatographic procedure in the test for Organic Impurities was validated using the XTerra RP18 brand of column with L1 packing. The typical retention time for lapatinib is about 24 min.

 (SM3: M. Jonnada)

 Case ID—SUB-1223