BRIEFING

 Rasagiline Tablets. 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 used in the Assay is based on analyses performed with the Develosil ODS-MG brand of column with L1 packing. The typical retention time for rasagiline is about 4 min.

2. The liquid chromatographic procedure in the Dissolution test is based on analyses performed with the Purospher STAR RP18e brand of column with L1 packing. The typical retention time for rasagiline is about 4 min.

3. The liquid chromatographic procedure in the test for Organic Impurities is based on analyses performed with the Develosil ODS-MG brand of column with L1 packing. The typical retention time for rasagiline is about 12 min.

4. The proposal includes a test for the Limit of Rasagiline Related Compound B by LC-MS and is based on analyses performed with the Acquity Premier BEH C18 brand of column with L1 packing. The detection was accomplished with a triple quadrupole mass spectrometer with ESI probe and positive ion mode. The typical retention time for rasagiline related compound B is about 6 min.

 (SM4: G. Daddala)

 Case ID—SUB-1229