SPL Set ID: 1ed9dde4-339c-486f-a346-dde33a5e493f
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, USP is N, N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown: Metformin hydrochloride USP is a white crystalline powder with a molecular formula of C 4 H 11 N 5 •HCl and a molecular weight of 165.62. Metformin hydrochloride USP 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, respectively. Each 500 mg and 1,000 mg tablet contains hypromellose, magnesium stearate, povidone, pregelatinized starch, ethylcellulose and polyethylene glycol. Composition of imprinting ink: Shellac, ferrosoferric oxide, propylene glycol and ammonium hydroxide. Metformin hydrochloride extended-release tablets meets USP Dissolution Test 26. structure