SPL Set ID: 17c65cba-f56f-4cad-a9e2-d31f62e95849
1 drug(s) with this SPL Set ID
Mexiletine hydrochloride, USP is an orally active antiarrhythmic agent. It is a white or almost white crystalline powder, freely soluble in water, Methanol and sparingly soluble in Methylene Chloride. Mexiletine hydrochloride, USP has a pKa of 9.2. The chemical name of mexiletine hydrochloride, USP is 1- methyl-2-(2,6-xylyloxy)ethylamine hydrochloride and its structural formula is: C 11 H 17 NO. HCl M. W. 215.72 g/mole Each capsule for oral administration, contains 150 mg, 200 mg, or 250 mg of mexiletine hydrochloride, USP. 100 mg of mexiletine hydrochloride, USP is equivalent to 83.31 mg of mexiletine base. In addition, each capsule contains the following excipients: colloidal silicon dioxide, magnesium stearate and partially pregelatinized maize starch. The capsule shell contains D & C Yellow #10, gelatin and titanium dioxide. The 150 mg and 250 mg also contain FD&C Blue #1, FD&C Red #40, The 150 mg and 200 mg also contain FD&C Yellow #6. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. The product complies with USP Dissolution Test 2. structure