Potency and Sterility of 10% Sodium Fluorescein Injection, USP Stored in Sterile Polypropylene Syringes for Use during Cystoscopy

Abstract

A shortage of indigotindisulfonate sodium has led to a search for an alternative visualizing agent. The primary objective of this study was to evaluate the potency and sterility of 10% sodium fluorescein, USP solutions stored in sterile polypropylene syringes and refrigerated. Four samples of 10% fluorescein injection, USP were aseptically drawn up in 3 mL polypropylene syringes and stored in a refrigerator at an average temperature of 3.9°C for 7 days. After 7 days, the samples were cultured for microbial growth. Four other samples were assayed by UV/VIS spectroscopy. Concentration measurements were made at day 0 and at day 7. The pH was also measured at day 0 and day 7. There was no statistical difference between the mean sodium fluorescein concentration at day 0 and at day 7 (α = 0.05, = .622). There was no statistical difference in the pH of the samples at day 0 and at day 7 (α = 0.05, = .0689). There was no evidence of microbial growth in any of the samples for the duration of the study period. The findings of this study demonstrate that a sterile solution of 10% sodium fluorescein, USP retained its potency and showed no signs of microbial growth for a period of 7 days when refrigerated and stored in sterile polypropylene syringes.

Sodium Fluorescein for Ureteral Jet Detection: A Prospective Observational Study

“…As only 1/20th of a vial is used to perform a cystoscopy, the rest of the dye can be used for other procedures. 25 …”