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

Dexamethasone Sodium Phosphate Ophthalmic Solution

»Dexamethasone Sodium Phosphate Ophthalmic Solution is a sterile,aqueous solution of Dexamethasone Sodium Phosphate.It contains 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 tight,light-resistant containers.

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.

pHá791ñ: between 6.6and 7.8.

Sterility á71ñ: meets the requirements.

Assay—

Mobile phase ,Standard preparation,and Chromatographic system—Prepare as directed in the Assayunder Dexamethasone Sodium Phosphate Injection.

Assay preparation— Transfer an accurately measured volume of Ophthalmic Solution,equivalent to about 8mg of dexamethasone phosphate,to a 100-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.

Procedure— Proceed as directed for Procedurein the Assayunder Dexamethasone Sodium Phosphate Injection.Calculate the quantity,in mg,of C22H30FO8Pin each mLof the Ophthalmic Solution taken by the formula:

0.1(C/V)(rU/rS),

in which Vis the volume,in mL,of Ophthalmic Solution taken.

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