BRIEFING

 Sunitinib 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 procedure in the Assay is based on analyses performed with the XBridge BEH Shield RP18 brand of column with L1 packing. The typical retention time for sunitinib is about 6 min.

2. The liquid chromatographic procedure in Dissolution Test 1 is based on analyses performed with the Zorbax Eclipse XDB-C18 brand of column with L1 packing. The typical retention time for sunitinib is about 0.9 min.

3. The liquid chromatographic procedure in Dissolution Test 2 is based on analyses performed with the Zorbax Eclipse XDB-C8 brand of column with L7 packing. The typical retention time for sunitinib is about 6 min.

4. The liquid chromatographic procedure in the test for Organic Impurities is based on analyses performed with the XBridge BEH Shield RP18 brand of column with L1 packing. The typical retention time for sunitinib is between 17–21 min. Under the acceptance criteria, User-Determined Reporting Thresholds 〈477〉 is referenced for user flexibility. Please see USP compendial notice “New Chapter 〈477〉 User-Determined Reporting Thresholds and its Implementation in USP-NF Monographs."

5. The liquid chromatographic procedure in the test for Limit of Desimidazoline Sunitinib is based on analyses performed with the XBridge BEH Shield RP18 brand of column with L1 packing. The typical retention times for desimidazoline sunitinib and sunitinib are about 4.5 and 14 min, respectively.

 (SM3: S. Ramakrishna)

 Correspondence Numbers—C315840, C322941