SPL Set ID: ef77c7dd-a65f-4adc-a0d9-a93779b459a0
1 drug(s) with this SPL Set ID
Metformin hydrochloride extended-release tablets USP contain the biguanidine 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 USP is a white crystalline powder that 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 deliver 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 hydrochloride USP, each tablet contains the following inactive ingredients: ammonio methacrylate copolymer type A, ammonio methacrylate copolymer type B, ammonium hydroxide, hydroxy propylcellulose, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polysorbate 80, propylene glycol, shellac, talc and triethyl citrate. FDA approved dissolution test differs from the USP monograph. Structure