Hydrocortisone Acetate Ointment
» Hydrocortisone Acetate Ointment is Hydrocortisone Acetate 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 C23H32O6.
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 acetate, to a flask, add 5 mL of methanol, and heat on a steam bath for 5 minutes with frequent mixing. 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. Locate the spots by spraying the dried plate with a 70% methanolic sulfuric acid solution. Heat the plate for 20 to 30 minutes at 90, allow to cool, and view under long-wavelength UV light: the RF value and fluorescence of the principal spot obtained from the test solution correspond to those obtained from the Standard solution.
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.
Assay Proceed with Ointment as directed in the Assay under Hydrocortisone Acetate Lotion.
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USP35NF30 Page 3436Pharmacopeial Forum: Volume No. 30(2) Page 504