1,3,5-Triazin-2(1H)-one, 4-amino-1-(2-deoxy-β-d-erythro-pentofuranosyl)-;
4-Amino-1-(2-deoxy-β-d-ribofuranosyl)-1,3,5-triazin-2(1H)-one; 2'-Deoxy-5-azacytidine; [2353-33-5]
BRIEFING
Decitabine. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed. The proposal for this drug substance which appeared in PF 45(4) [Jul.–Aug. 2019] was canceled and is replaced with a new proposal:
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The liquid chromatographic procedure in the Assay and 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 9 min.
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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 is about 23 min.
(SM3: S. Shane)
Case ID—SUB-1957, SUB-1972, SUB-1973