SPL Set ID: 2d99893a-296a-134c-e063-6294a90ace3b

1 drug(s) with this SPL Set ID

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ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE
COUPLER LLC FDA Rx Only

Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Each tablet, for oral administration, contains either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The molecular formula of isosorbide mononitrate is C 6 H 9 NO 6 and the molecular weight is 191.14. The chemical name for isosorbide mononitrate is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula: Isosorbide mononitrate is a white needle crystal or crystalline powder which is stable in air and in solution, has a melting point of about 90°C, and a specific rotation of +170° to +176° Isosorbide mononitrate is freely soluble in methanol or acetone, soluble in water or chloroform, and practically insoluble in hexane. FDA approved dissolution test specifications differs from USP.

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