2-Azabicyclo[3.1.0]hexane-3-carbonitrile, 2-[(2S)-amino(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-, hydrate (1:1), (1S,3S,5S)-;
(1S,3S,5S)-2-[(2S)-Amino(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile monohydrate [945667-22-1]
BRIEFING
Saxagliptin. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed. The liquid chromatographic procedures used in the Assay and the test for Organic Impurities are based on validation performed with the Zorbax Eclipse AAA brand of column with L1 packing. The typical retention time for saxagliptin is about 21 min in the Assay and Organic Impurities test.
Description and Solubility information: White to light yellow or light brown powder which may contain lumps. Soluble in methanol, in ethanol, in isopropyl alcohol, in acetonitrile, in acetone, and in polyethylene glycol 400; sparingly soluble in water; slightly soluble in ethyl acetate.
(SM3: P. Pabba)
Case-ID—SUB-773