Fluorescein Injection
»Fluorescein Injection is a sterile solution,in Water for Injection,of Fluorescein prepared with the aid of Sodium Hydroxide.It contains the equivalent of not less than 90.0percent and not more than 110.0percent of the labeled amount of fluorescein sodium (C20H10Na2O5).It may contain Sodium Bicarbonate.
Packaging and storage— Preserve in single-dose containers,preferably of Type Iglass.
Identification— It responds to Identificationtests Aand Cunder Fluorescein Sodium.
Pyrogen— It meets the requirements of the Pyrogen Test á151ñ,the test dose being the equivalent of 250mg of fluorescein sodium per kg.
pHá791ñ: between 8.0and 9.8.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Standard preparation— Prepare as directed in the Assayunder Fluorescein Sodium.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 100mg of fluorescein sodium,and dilute quantitatively and stepwise with water to obtain a solution having a concentration of 1µg per mL.Transfer 3.0mLof this 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)equivalent in the Injection taken by the formula:
3333C(IU/IS),
in which Cis the concentration,in µg per mL,of fluorescein sodium in the Standard preparation;and IUand ISare the fluorescence values observed for the Assay preparationand the Standard preparation,respectively.
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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