BRIEFING

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

1. The liquid chromatographic procedures used in the Assay and the test for Organic Impurities were validated using the Xterra RP 18 brand of column with L1 packing. The typical retention time for nilotinib is about 10 min.

2. The liquid chromatographic procedure used in the test for Limit of Nilotinib Related Compound A was validated using the ProntoSIL C18-ace-EPS brand of column with L1 packing. The typical retention time for nilotinib related compound A is about 6 min.

 Manufacturers are encouraged to share any information pertaining to the mutagenicity of nilotinib related compound A with USP.

 (SM3: R. Fales)

 Case ID—SUB-458