Hydrocortisone Acetate Ophthalmic Ointment, chemical structure, molecular formula, Reference Standards

Hydrocortisone Acetate Ophthalmic Ointment

»Hydrocortisone Acetate Ophthalmic Ointment is Hydrocortisone Acetate in a suitable ophthalmic ointment base.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of total steroids,calculated as C23H32O6.It is sterile.

Packaging and storage— Preserve in collapsible ophthalmic ointment tubes.

USP Reference standards á11ñ— USP Hydrocortisone Acetate RS.

Identification— It responds to the Identificationtest under Hydrocortisone Acetate Ointment.

Sterility á71ñ: meets the requirements.

Minimum fill á755ñ: meets the requirements.

Particulate matter— It meets the requirements of the test for Metal Particles in Ophthalmic Ointments á751ñ.

Assay—

Standard preparation— Prepare as directed for Standard Preparationunder Assay for Steroids á351ñ,using USP Hydrocortisone Acetate RS.

Assay preparation— Transfer to a suitable flask an accurately weighed quantity of Ophthalmic Ointment,equivalent to about 10mg of hydrocortisone acetate,and add 30mLof 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-mLvolumetric flask.Repeat the extraction with three 20-mLportions of alcohol,add alcohol to volume,and mix.Pipet 10mLof this solution into a 100-mLvolumetric flask,add alcohol to volume,and mix.Pipet 20mLof the resulting solution into a glass-stoppered,50-mLconical flask.

Procedure— Proceed as directed for Procedureunder Assay for Steroids á351ñ.Calculate the quantity,in mg,of C23H32O6in the portion of Ophthalmic Ointment taken by the formula:

C(AU/AS),

in which the terms are as defined therein.

Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 964

Phone Number:1-301-816-8139