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Idoxuridine Ophthalmic Solution
»Idoxuridine Ophthalmic Solution is a sterile,aqueous solution of Idoxuridine.It contains not less than 0.09percent and not more than 0.11percent 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 UVabsorption spectrum of the solution employed for measurement of absorbance in the Assayexhibits maxima and minima at the same wavelengths as that of the Standard preparationprepared for the Assay.
Sterilityá71ñ:
meets the requirements.
pHá791ñ:
between 4.5and 7.0.
Assay—
Chromatographic column
and Standard preparation—Prepare as directed in the Assayunder Idoxuridine Ophthalmic Ointment.
Assay preparation—
Mix an accurately measured volume of Ophthalmic Solution,equivalent to about 5mg of idoxuridine,with 3g of chromatographic siliceous earth in a glass mortar until the mixture is fluffy.
Procedure—
Proceed as directed for Procedurein the Assayunder Idoxuridine Ophthalmic Ointment,omitting the treatment of the column with 50mLof chloroform.Calculate the quantity,in mg,of C9H11IN2O5in each mLof the Ophthalmic Solution taken by the formula:
0.2C(A283-A320)U/V(A283-A320)S,
in which Cis the concentration,in µg per mL,of USP Idoxuridine RSin the Standard preparation;Vis 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:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 997
Phone Number:1-301-816-8394
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