SPL Set ID: e8b86758-6cb5-44ac-a5fc-2111e98a19a8

Indomethacin Oral Suspension, USP is a nonsteroidal anti-inflammatory drug, available as an oral suspension containing 25 mg of indomethacin per 5 mL, alcohol 1% v/v, and sorbic acid 0.1% added as a preservative for oral administration. The chemical name is -(4-chlorobenzoyl)-5-methoxy-2-methyl-1 H -indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C 19 H 16 ClNO 4 , and it has the following chemical structure. Indomethacin is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. Indomethacin has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The suspension has a pH of 2.5-5.0. Indomethacin Oral Suspension, USP 25 mg per 5 mL is an off-white suspension with cherry flavor free from extraneous particles. The inactive ingredients in Indomethacin Oral Suspension, USP include: sorbic acid, sorbitol solution, alcohol (1% v/v), simethicone emulsion, xanthan gum, sodium hydroxide to adjust pH, artificial cherry flavor (including flavoring ingredients and alcohol) and purified water. FDA approved dissolution test specifications differ from USP. structure