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Each FDT contains lansoprazole which is in the form of enteric-coated microgranules.
Each vial contains lansoprazole which occurs as a white to brownish white crystalline powder with the molecular formula of C16H14F3N3O2S, molecular weight of 369.36 and a melting point of 166 °C (decomposed). It is freely soluble in N,N-dimethylforamide, soluble in methanol, sparingly soluble in ethanol (99.5), and practically insoluble in water.
It has a pH of 10.6-11.3 [when dissolved in 5 mL of isotonic sodium chloride solution (JP)] and an osmotic pressure ratio of approximately 1 [when dissolved in 5 mL of isotonic sodium chloride solution (JP)].
Lansoprazole is (±)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)pyridine-2-yl] methyl}sulfinyl]-1H-benzimidazole.
