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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 90.0 percent and not more than 110.0 percent of the labeled amount of fluorescein sodium (C20H10Na2O5). It may contain Sodium Bicarbonate.
Packaging and storage— Preserve in single-dose containers, preferably of Type I glass.
Identification— It responds to Identification tests A and C under Fluorescein Sodium.
Pyrogen— It meets the requirements of the Pyrogen Test 151, the test dose being the equivalent of 250 mg of fluorescein sodium per kg.
pH 791: between 8.0 and 9.8.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Standard preparation— Prepare as directed in the Assay under Fluorescein Sodium.
Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 100 mg of fluorescein sodium, and dilute quantitatively and stepwise with water to obtain a solution having a concentration of 1 µg per mL. Transfer 3.0 mL of this solution to a 100-mL volumetric flask containing 20 mL of pH 9.0 alkaline borate buffer (see Buffer Solutions in the section Reagents, Indicators, and Solutions), dilute with water to volume, and mix.
Procedure— Proceed as directed for Procedure in the Assay under Fluorescein Sodium. Calculate the quantity, in mg, of fluorescein sodium (C20H10Na2O5) equivalent in the Injection taken by the formula:
3333C(IU / IS),
in which C is the concentration, in µg per mL, of fluorescein sodium in the Standard preparation; and IU and IS are the fluorescence values observed for the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Feiwen Mao, M.S., Senior Scientific Associate
Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
USP29–NF24 Page 931
Phone Number : 1-301-816-8320