» Hydrocortisone Ointment is Hydrocortisone in a suitable ointment base. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of hydrocortisone (C21H30O5).
Packaging and storage Preserve in well-closed containers.
USP Reference standards 11
Identification Transfer a quantity of Ointment, equivalent to about 5 mg of hydrocortisone, to a flask, add 10 mL of methanol, and heat on a steam bath for 5 minutes with frequent shaking. Cool to solidify the ointment base, and filter. Using the filtrate as the test solution, proceed as directed under Thin-layer Chromatographic Identification Test 201.
Microbial enumeration tests 61 and Tests for specified microorganisms 62 It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa.
Minimum fill 755: meets the requirements.
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USP35NF30 Page 3432