BRIEFING

 Cevimeline Hydrochloride 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 was validated using the Xbridge C18 brand of column with L1 packing. The typical retention time for cevimeline is about 3 min.

2. The liquid chromatographic procedure in the test for Dissolution was validated using the Xbridge C18 brand of column with L1 packing. The typical retention time for cevimeline is about 2 min.

3. The liquid chromatographic procedure in the test for Organic Impurities was validated using the Xbridge C18 brand of column with L1 packing. The typical retention time for cevimeline is about 12 min.

4. The liquid chromatographic procedure in the test for Limit of Cevimeline Related Compound A and Cevimeline Sulfoxide was validated using the Xbridge C18 brand of column with L1 packing. The typical retention times for cevimeline sulfoxide and cevimeline related compound A are about 2 and 4 min, respectively.

 (SM4: R. Ivaturi)

 Case ID—SUB-1186