U.S. PHARMACOPEIA

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Dexamethasone Sodium Phosphate Ophthalmic Ointment
» Dexamethasone Sodium Phosphate Ophthalmic Ointment is a sterile ointment containing an amount of dexamethasone sodium phosphate (C22H28FNa2O8P) equivalent to not less than 90.0 percent and not more than 115.0 percent of the labeled amount of dexamethasone phosphate (C22H30FO8P).
Packaging and storage— Preserve in collapsible ophthalmic ointment tubes.
Identification— The Assay preparation, prepared as directed in the Assay, responds to the Identification test under Dexamethasone Sodium Phosphate Cream.
Minimum fill 755: meets the requirements.
Sterility 71: meets the requirements.
Metal particles— 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—
Alcohol-aqueous phosphate buffer , 0.05 M Phosphate buffer, Mobile phase, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Dexamethasone Sodium Phosphate Cream.
Assay preparation— Using an accurately weighed portion of Ophthalmic Ointment, prepare as directed in the Assay under Dexamethasone Sodium Phosphate Cream.
Procedure— Proceed as directed for Procedure in the Assay under Dexamethasone Sodium Phosphate Cream. Calculate the quantity, in mg, of C22H30FO8P in the portion of Ophthalmic Ointment taken by the formula:
0.1C(rU / rS).
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 652
Phone Number : 1-301-816-8143