Jimandin Description

Light brown, round, biconvex film coated tablets with diameter approximately 10.3 mm.
Each Jimandin 100 mg film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
SITAGLIPTIN Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme.
Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5- trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate.
The empirical formula is C₁₆H₁₅F₆N₅O·H₃PO₄·H₂O and the molecular weight is 523.32.
Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate.
Each film-coated tablet of SITAGLIPTIN contains 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 100 mg, respectively, of free base and the following inactive ingredients.
Excipients/Inactive Ingredients: Tablet core: Microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate, croscarmellose sodium, magnesium stearate, sodium stearyl fumarate, and propyl gallate.
Coating: In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol (E1203), polyethylene glycol/macrogol (E1521), talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).