Hydrocortisone Ointment
» 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
USP Hydrocortisone RS Click to View Structure
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.
Assay— Proceed with Ointment as directed in the Assay under Hydrocortisone Cream, except to read Ointment instead of Cream, and to use alcohol instead of methanol.
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Topic/Question Contact Expert Committee
Monograph Domenick Vicchio, Ph.D.
Senior Scientific Liaison
1-301-998-6828
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
61 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
1-301-816-8339
(GCM2010) General Chapters - Microbiology
62 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
1-301-816-8339
(GCM2010) General Chapters - Microbiology
USP35–NF30 Page 3432