BRIEFING

 Busulfan Injection. 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 for the Assay is validated with the YMC-Pack ODS-A brand of column with L1 packing. The typical retention time for derivatized busulfan is about 13 min.

2. The liquid chromatographic procedure for the Organic Impurities test is validated using the ZORBAX Eclipse XDB-C8 brand of column with L7 packing. The typical retention time for busulfan is about 8 min.

3. The ion chromatographic procedure for the Limit of Methanesulfonic Acid test is validated with the Metrosep A Supp 5 brand of column with L132 packing. The typical retention time for methanesulfonic acid is about 12 min.

4. The gas chromatographic procedure for the Limit of Tetrahydrofuran and 1,4-Butanediol test is validated with the Zebron ZB-Wax brand of column with phase G16. The typical retention times for tetrahydrofuran and 1,4-butanediol are about 3 and 17 min, respectively.

5. The liquid chromatographic procedure for the Limit of Busulfan Acetate is validated using the Hypersil BDS C18 brand of column with L1 packing. The typical retention time for derivatized busulfan acetate is about 6 min.

 (SM3: J. Li)

 Case ID—SUB-1146, SUB-1167