SPL Set ID: 9468a2f3-3ebe-40bd-a3b4-d78d9eb47e04
1 drug(s) with this SPL Set ID
BRYNOVIN (sitagliptin) oral solution contains sitagliptin hydrochloride (HCl), an orally-active inhibitor of the DPP-4 enzyme. Sitagliptin HCl is described chemically as ((3R)-3-Amino-1-(3-(trifluoromethy1)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-y1)-4-(2,4,5-trifluorophenyl)butan-l-one HCl monohydrate. The empirical formula is C 16 H 15 F 6 N 5 O•HCl.H 2 O and the molecular weight is 461.79. The structural formula is: Sitagliptin HCl is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water; very slightly soluble in ethanol; and practically insoluble in n-Heptane. BRYNOVIN oral solution is a clear, colorless to nearly colorless oral solution. Each mL contains 27.24 mg of sitagliptin HCl, equivalent to 25 mg of sitagliptin. BRYNOVIN contains the following inactive ingredients: butylated hydroxyanisole, citric acid anhydrous, edetate disodium, hydroxyethyl cellulose, methylparaben sodium, polysorbate 80, purified water, sodium citrate dihydrate, and sweetener/flavoring agent. Structure