Indomethacin Topical Gel
» Indomethacin Topical Gel contains not less than 0.90 g and not more than 1.10 g of Indomethacin in 100 mL of gel. Prepare Indomethacin Topical Gel as follows:
Indomethacin 1.0 g
Carbomer 941 2.0 g
Purified Water 10 mL
Alcohol (95% ethyl alcohol), a sufficient quantity to make 100 mL
Transfer the Indomethacin to a suitable beaker, and dissolve it in 55 mL of Alcohol. Transfer this solution to a glass mortar, and slowly add the Carbomer 941 so that it is thoroughly distributed. Press out any white lumps until a smooth gel is formed. Slowly add the Purified Water with mixing. Add a sufficient quantity of Alcohol to obtain a final volume of 100 mL, and mix. Transfer the Gel to a wide-mouth container or ointment jar.
Packaging and storage— Preserve in tight, light-resistant, wide-mouth containers or ointment jars. Store at controlled room temperature.
Labeling— Label it to state that it is for topical, external use only, that it should be used only as directed, and that the container should be kept tightly closed.
Beyond-use date— Thirty days after the day on which it was compounded.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Jeanne H. Sun
Assistant Scientific Liaison
(CMP2010) Compounding
USP35–NF30 Page 3499
Pharmacopeial Forum: Volume No. 30(3) Page 866