BRIEFING

 Regorafenib 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 procedures in the Assay and the test for Organic Impurities were validated using the YMC-Pack Pro C18 RS brand of column with L1 packing. The typical retention time for regorafenib is about 11 min.

2. The liquid chromatographic procedure in the test for Limit of Regorafenib Related Compound A was validated using the Gemini C18 brand of column with L1 packing. The typical retention time for regorafenib related compound A is about 13 min.

 This proposal has been retroactively aligned with the European Pharmacopoeia in European Pharmacopoeia edition 11.1.

 (SM3: L. Lasker)

 Case ID—SUB-1915