U.S. PHARMACOPEIA

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Idoxuridine Ophthalmic Solution
» Idoxuridine Ophthalmic Solution is a sterile, aqueous solution of Idoxuridine. It contains not less than 0.09 percent and not more than 0.11 percent of C9H11IN2O5. It may contain suitable buffers, stabilizers, and antimicrobial agents.
Packaging and storage— Preserve in tight, light-resistant containers in a cold place.
Identification— The UV absorption spectrum of the solution employed for measurement of absorbance in the Assay exhibits maxima and minima at the same wavelengths as that of the Standard preparation prepared for the Assay.
Sterility71: meets the requirements.
pH 791: between 4.5 and 7.0.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Chromatographic column and Standard preparation—Prepare as directed in the Assay under Idoxuridine Ophthalmic Ointment.
Assay preparation— Mix an accurately measured volume of Ophthalmic Solution, equivalent to about 5 mg of idoxuridine, with 3 g of chromatographic siliceous earth in a glass mortar until the mixture is fluffy.
Procedure— Proceed as directed for Procedure in the Assay under Idoxuridine Ophthalmic Ointment, omitting the treatment of the column with 50 mL of chloroform. Calculate the quantity, in mg, of C9H11IN2O5 in each mL of the Ophthalmic Solution taken by the formula:
0.2C(A283 A320)U / V(A283 A320)S,
in which C is the concentration, in µg per mL, of USP Idoxuridine RS in the Standard preparation; V is the volume, in mL, of Ophthalmic Solution taken; and the parenthetic expressions are the differences in the absorbances of the two solutions at the wavelengths indicated by the subscripts, for the Solution (U) and the Standard preparation (S), respectively.
Auxiliary Information— Staff Liaison : Behnam Davani, Ph.D., MBA, Senior Scientist
Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials
USP29–NF24 Page 1107
Phone Number : 1-301-816-8394