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 90.0 percent and not more than 115.0 percent of the labeled amount of dexamethasone phosphate (C22H30FO8P).
Packaging and storage— Preserve in tight, light-resistant containers.
Identification— The Assay preparation, prepared as directed in the Assay, responds to the Identification test under Dexamethasone Sodium Phosphate Cream.
pH 791: between 6.6 and 7.8.
Sterility 71: meets the requirements.
Mobile phase, Standard preparation, and Chromatographic system— Prepare as directed in the Assay under Dexamethasone Sodium Phosphate Injection.
Assay preparation— Transfer an accurately measured volume of Ophthalmic Solution, equivalent to about 8 mg of dexamethasone phosphate, to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure— Proceed as directed for Procedure in the Assay under Dexamethasone Sodium Phosphate Injection. Calculate the quantity, in mg, of C22H30FO8P in each mL of the Ophthalmic Solution taken by the formula:
0.1(C / V)(rU / rS)
in which V is the volume, in mL, of Ophthalmic Solution taken.
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
(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2093
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.