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.
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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Daniel K. Bempong, Ph.D.
Senior Scientist
1-301-816-8143		 (MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
61 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
62 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2575
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.