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.
USP Reference standards 11
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.
Alcohol-aqueous phosphate buffer , 0.05 M Phosphate buffer, Mobile phase, Standard preparation, and Chromatographic systemPrepare 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.
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USP35NF30 Page 2846