SPL Set ID: 7c911ac4-db70-44bf-8374-01c8260aa3d4

Indomethacin Suppositories, USP are a nonsteroidal anti-inflammatory drug, available as a suppository containing 50 mg of indomethacin, USP administered for rectal use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1 H -indole-3-acetic acid. The molecular weight is 357.79. Its molecular formula is C 19 H 16 ClNO 4 and it has the following chemical structure. Indomethacin, USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol, in chloroform, and in ether. It has a pKa of 4.27 and is stable in neutral or slightly acidic media and decomposes in strong alkali. Each indomethacin suppository contains hard fat as an inactive ingredient. Indomethacin suppositories, USP, 50 mg each, are off-white to yellowish white, torpedo shaped, rectal suppositories. FDA approved dissolution test specifications differ from USP. Image