BRIEFING

 Decitabine for 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 in the Assay was validated using the Zorbax Bonus-RP brand of column with L60 packing. The typical retention time for decitabine is about 11 min.

2. The liquid chromatographic procedure in the test for Organic Impurities was validated using the Zorbax Bonus-RP brand of column with L60 packing. The typical retention time for decitabine is about 10 min.

3. The liquid chromatographic procedure in the test for Limit of Decitabine Related Compound F was validated using the Atlantis HILIC Silica brand of column with L3 packing. The typical retention time for decitabine related compound F (all isomers) is in the range of 15–35 min.

4. The liquid chromatographic procedure in the test for Limit of Azacitidine Related Compound A is based on analyses performed with the YMC-Triart C18 brand of column with L1 packing. The typical retention time for azacitidine related compound A is about 5 min.

 (SM3: S. Shane)

 Case ID—SUB-1864, SUB-1929, SUB-1950