SPL Set ID: e0b5f0ed-ff40-4f0d-bb86-81a7ace9f339

Risedronate sodium tablets are pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each risedronate sodium tablet, USP for oral administration contains the equivalent of 5 mg, 30 mg, 35 mg, 75 mg, or 150 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate. The molecular formula for risedronate sodium hemi-pentahydrate, USP is C 7 H 10 NO 7 P 2 Na •2.5 H 2 O. The chemical name of risedronate sodium is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium hemi-pentahydrate is the following: Risedronate sodium is a fine, white to off-white, odorless, crystalline powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents. Inactive Ingredients All dose strengths contain: mannitol, microcrystalline cellulose, croscarmellose sodium, pregelatinized maize starch, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc. Dose strength-specific ingredients include: 5 mg—iron oxide yellow; 35 mg— iron oxide red, iron oxide yellow; 75 mg— iron oxide red; 150 mg—FD&C blue #2 aluminum lake. For 75 mg and 150 mg strengths - FDA approved dissolution test specifications differ from USP. risedronate-sodium-structure