Fluorescein Sodium Ophthalmic Strips
»Fluorescein Sodium Ophthalmic Strips contain not less than 100.0percent and not more than 160.0percent of the labeled amount of fluorescein sodium (C20H10Na2O5).
Packaging and storage— Package not more than 2Strips in a single-unit container in such manner as to maintain sterility until the package is opened.Package individual packages in a second protective container.
Labeling— The label of the second protective container bears a statement that the contents may not be sterile if the individual package has been damaged or previously opened.The label states the amount of fluorescein sodium in each Strip.
Identification— Cut the colored tip from 1Strip,place it in a small test tube containing 1mLof water,and agitate for 1minute:the resulting solution of fluorescein sodium responds to Identificationtests Aand Cunder Fluorescein Sodium.
Sterility á71ñ: meets the requirements.
Content uniformity— The content of C20H10Na2O5in each of not less than 10Strips,determined as directed in the Assay,is not less than 85.0%and not more than 175.0%of the labeled amount.
Assay—
Standard preparation— Prepare as directed in the Assayunder Fluorescein Sodium.
Assay preparation— Remove 1Strip from its package,taking care not to allow any portion of the tip to adhere to the packaging material,transfer to a 100-mLvolumetric flask,add 50mLof water,shake the flask vigorously,and dilute with water to volume.Shake occasionally,and,after 1hour,mix the contents of the flask.Transfer an aliquot (V)of this solution,equivalent to about 100µg of fluorescein sodium,to a 100-mLvolumetric flask,dilute with water to volume,and mix.Transfer 3mLof the resulting solution to a 100-mLvolumetric flask containing 20mLof pH9.0alkaline borate buffer (see Buffer Solutionsin the section Reagents,Indicators,and Solutions),dilute with water to volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Fluorescein Sodium.Calculate the quantity,in mg,of fluorescein sodium (C20H10Na2O5)in the Strip taken by the formula:
(333)(C/V)(IU/IS),
in which Cis the concentration,in µg per mL,of fluorescein sodium in the Standard preparation;Vis the volume of the aliquot of solution taken for the Assay preparation;and IUand ISare the fluorescence intensities observed for the Assay preparationand the Standard preparation,respectively.Calculate the average content from the individual assays of not less than 10Strips.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 844
Phone Number:1-301-816-8389
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