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:
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.
USP32NF27 Page 2635Pharmacopeial Forum: Volume No. 30(3) Page 866