Indomethacin Compounded Topical Gel
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Indomethacin Compounded Topical Gel contains NLT 0.90 g and NMT 1.10 g of Indomethacin in 100 mL of gel.
Prepare Indomethacin Compounded 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 bring to final volume, and mix. Transfer the Topical Gel to a wide-mouth container or ointment jar.
2 ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Package in tight, light-resistant, wide-mouth containers or ointment jars. Store at controlled room temperature.
BEYOND-USE DATE: NMT 30 days after the date on which it was compounded when stored at controlled room temperature
LABELING: Label it to state that it is for topical, external use only. Label it to indicate that the container should be kept tightly closed. Label it to state the Beyond-Use Date.
