SPL Set ID: 16dc4008-7b5e-4c6d-9bc8-8db96be911a1
1 drug(s) with this SPL Set ID
Metformin hydrochloride extended-release tablets, USP contain the biguanide antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin hydrochloride is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C 4 H 11 N 5 •HCl and a molecular weight of 165.63. Its structural formula is: Metformin hydrochloride is a white to off-white crystalline powder that freely soluble in water, slightly soluble in alcohol and is practically insoluble in acetone and methylene chloride. 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 contain 500 mg or 1,000 mg of metformin hydrochloride, USP which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains ammonio methacrylate copolymer, hypromellose, magnesium stearate, pregelatinized starch (maize), polyethylene glycol, polyvinylpyrrolidone, silicon dioxide, talc, titanium dioxide and triethyl citrate. Metformin hydrochloride extended-release tablets USP meets USP Dissolution Test 12. Formula