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.
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— 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
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2092
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.