SPL Set ID: 85027e6c-d35b-49eb-a234-dd71aa77aee0
1 drug(s) with this SPL Set ID
Metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N -dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below: 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 165.63. Metformin hydrochloride is 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, USP contains 500 mg or 750 mg of metformin hydrochloride, USP as the active ingredient. Metformin hydrochloride extended-release tablets, USP 500 mg and 750 mg contains the inactive ingredients glyceryl behenate, hypromellose, microcrystalline cellulose and povidone. The methodology used for dissolution testing is USP Test 8 for metformin hydrochloride extended-release tablets, USP. Image