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

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

Enrique Puertos, Greta Giles

Hosp Pharm. 2016 Oct;51(9):778-781.

PMID: 27803508

Abstract:

Background: A shortage of indigotindisulfonate sodium has led to a search for an alternative visualizing agent. Objective: 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. Methods: 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. Results: There was no statistical difference between the mean sodium fluorescein concentration at day 0 and at day 7 (α = 0.05, p = .622). There was no statistical difference in the pH of the samples at day 0 and at day 7 (α = 0.05, p = .0689). There was no evidence of microbial growth in any of the samples for the duration of the study period. Conclusions: 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.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP860220-B	Indigotindisulfonate sodium		860-22-0	Price

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