BRIEFING

 Cytarabine Injection. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed. The liquid chromatographic procedure for the Assay was validated using the µBondapak C18 brand of column with L1 packing, and the typical retention time for cytarabine is about 7 min. The liquid chromatographic procedure for the test for Organic Impurities was validated using the Supelcosil LC-18-DB brand of column with L1 packing, and the typical retention time for cytarabine is about 8 min.

 (SM3: J. Li)

 Case ID—SUB-615