SPL Set ID: 1200ea71-8a9e-4e49-bb77-7d9fe0d84ae7
1 drug(s) with this SPL Set ID
Metformin hydrochloride extended-release tablets, USP contains 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, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. Each tablet contains ammonio methacrylate copolymer, colloidal silicon dioxide, dibutyl sebacate, hypromellose, magnesium stearate, microcrystalline cellulose, povidone and talc. Metformin hydrochloride extended-release tablets USP, 500 mg meets USP Dissolution Test 13. FDA approved dissolution test specification differ from USP for Metformin hydrochloride extended-release tablets USP, 1000 mg. Image-01