USPUSP-NF
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Decitabine
C8H12N4O4 228.21
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:

  1. 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.

  2. 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.

Description and Solubility Information: White to off-white powder. Soluble in dimethylsulfoxide; sparingly soluble in water; slightly soluble in ethanol and water (50:50), in methanol and water (50:50), and in methanol.

 (SM3: S. Shane)

 Case ID—SUB-1957, SUB-1972, SUB-1973

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