SPL Set ID: 82d793ee-4039-45fc-ac83-4bd5235f00aa

Escitalopram oral solution, USP contains escitalopram oxalate USP, a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate, USP is designated S-(+)-1-[3(dimethyl-amino)propyl]-1-( p -fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula: The molecular formula is C 20 H 21 FN 2 O • C 2 H 2 O 4 and the molecular weight is 414.40. Escitalopram oxalate, USP occurs as a fine, white to slightly-yellow color powder and is freely soluble in methanol and in dimethyl sulfoxide, sparingly soluble in water and in alcohol, very slightly soluble in ethyl acetate and in isopropyl alcohol, insoluble in heptane. Escitalopram oral solution, USP contains 1.29 mg/mL escitalopram oxalate, USP equivalent to 1 mg/mL escitalopram base. It also contains the following inactive ingredients: anhydrous citric acid, glycerin, malic acid, methylparaben, natural peppermint flavor, non-crystallizing sorbital solution, propylene glycol, propylparaben, purified water and sodium citrate dihydrate. FDA approved pH and organic impurities specification differs from the USP pH and organic impurities specification. escitalopram-structure