BRIEFING

 Clobazam Oral Suspension. 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 procedure in the Assay was validated using the Kromasil C18 brand of column with L1 packing. The typical retention time for clobazam is about 5 min.

2. The liquid chromatographic procedure in the Dissolution test was validated using the Poroshell 120 SB-C18 brand of column with L1 packing. The typical retention time for clobazam is about 1 min.

3. The liquid chromatographic procedure in the test for Organic Impurities was validated using the Kromasil 100-C18 brand of column with L1 packing. The typical retention time for clobazam is about 16 min.

4. The liquid chromatographic procedure in the Limit of Clobazam Related Compound G test was validated using the YMC Pack ODS AQ brand of column with L1 packing. The typical retention times for clobazam related compound G and clobazam are about 10 and 16 min, respectively.

5. The liquid chromatographic procedure in the Content of Salicylic Acid Related Compound A test was validated using the YMC Pack ODS AQ brand of column with L1 packing. The typical retention time for salicylic acid related compound A is about 5 min.

 (SM4: S. Singireddy)

 Case ID—SUB-1034, SUB-1036, SUB-1044, and SUB-3205