Dexamethasone Sodium Phosphate Ophthalmic Ointment, chemical structure, molecular formula, Reference Standards

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 90.0percent and not more than 115.0percent of the labeled amount of dexamethasone phosphate (C22H30FO8P).

Packaging and storage— Preserve in collapsible ophthalmic ointment tubes.

USP Reference standards á11ñ— USP Dexamethasone RS.USP Dexamethasone Phosphate RS.

Identification— The Assay preparation,prepared as directed in the Assay,responds to the Identificationtest under Dexamethasone Sodium Phosphate Cream.

Minimum fill á755ñ: meets the requirements.

Sterility á71ñ: meets the requirements.

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

Assay—

Alcohol-aqueous phosphate buffer ,0.05M Phosphate buffer,Mobile phase,Standard preparation,and Chromatographic system—Prepare as directed in the Assayunder Dexamethasone Sodium Phosphate Cream.

Assay preparation— Using an accurately weighed portion of Ophthalmic Ointment,prepare as directed in the Assayunder Dexamethasone Sodium Phosphate Cream.

Procedure— Proceed as directed for Procedurein the Assayunder Dexamethasone Sodium Phosphate Cream.Calculate the quantity,in mg,of C22H30FO8Pin the portion of Ophthalmic Ointment taken by the formula:

0.1C(rU/rS).

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

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 596

Phone Number:1-301-816-8139