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.
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.
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.
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.
755:
meets the requirements.
Assay—
Proceed with Ointment as directed in the Assay under Hydrocortisone Acetate Lotion.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
Chromatographic Column—
| 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 2578
Pharmacopeial Forum: Volume No. 30(2) Page 504
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.