SPL Set ID: 1016cad7-2198-483c-893b-e25fd397a226
1 drug(s) with this SPL Set ID
Metformin hydrochloride extended release tablets contain the biguanide antihyperglycemic agent metformin in the form of monohydrochloride salt. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown: Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4 H 11 N 5 •HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP, contain 500 mg or 1,000 mg of metformin hydrochloride, USP, which is equivalent to 389.93 mg or 779.86 mg metformin. Each 500 mg tablet contains ammonium hydroxide, black iron oxide non-irradiated, colloidal silicon dioxide, crospovidone, glyceryl dibehenate, hypromellose, poly (vinyl acetate) dispersion 30 percent, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, povidone, shellac glaze (modieied) in SD-45, talc, titanium dioxide, and triethyl citrate. Each 1,000 mg tablet contains ammonium hydroxide, black iron oxide non-irradiated, colloidal silicon dioxide, crospovidone, glyceryl dibehenate, hypromellose, poly (vinyl acetate) dispersion 30 percent, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, povidone, shellac glaze (modieied) in SD-45, talc, titanium dioxide, and triethyl citrate. FDA approved dissolution test specifications differ from USP. structural formula