U.S. PHARMACOPEIA

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Hydrocortisone Acetate Ophthalmic Ointment
» Hydrocortisone Acetate Ophthalmic Ointment is Hydrocortisone Acetate in a suitable ophthalmic ointment base. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of total steroids, calculated as C23H32O6. It is sterile.
Packaging and storage— Preserve in collapsible ophthalmic ointment tubes.
Identification— It responds to the Identification test under Hydrocortisone Acetate Ointment.
Sterility 71: meets the requirements.
Minimum fill 755: meets the requirements.
Particulate matter— It meets the requirements of the test for Metal Particles in Ophthalmic Ointments 751.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Standard preparation— Prepare as directed for Standard Preparation under Assay for Steroids 351, using USP Hydrocortisone Acetate RS.
Assay preparation— Transfer to a suitable flask an accurately weighed quantity of Ophthalmic Ointment, equivalent to about 10 mg of hydrocortisone acetate, and add 30 mL of alcohol. Heat on a steam bath to melt the ointment base, and mix. Cool to solidify the ointment base, and filter the alcohol solution into a 100-mL volumetric flask. Repeat the extraction with three 20-mL portions of alcohol, add alcohol to volume, and mix. Pipet 10 mL of this solution into a 100-mL volumetric flask, add alcohol to volume, and mix. Pipet 20 mL of the resulting solution into a glass-stoppered, 50-mL conical flask.
Procedure— Proceed as directed for Procedure under Assay for Steroids 351. Calculate the quantity, in mg, of C23H32O6 in the portion of Ophthalmic Ointment taken by the formula:
C(AU / AS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 1072
Phone Number : 1-301-816-8143