Indomethacin Topical Gel
DEFINITION
Indomethacin Topical Gel contains NLT 0.90 g and NMT 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 bring to final volume, and mix. Transfer the Gel to a wide-mouth container or ointment jar.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Package 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. Label to indicate that it should be used only as directed and that the container should be kept tightly closed.
• Beyond-Use Date:
NMT 30 days after the date 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, Pharm.D.
Associate Scientific Liaison (301) 230-3361 |
(CMP2010) Compounding |
USP38–NF33 Page 3864
Pharmacopeial Forum: Volume No. 40(6)