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American Journal of Health-System Pharmacy, Vol. 65, Issue 2, 142-144
Copyright © 2008. American Society of Health-System Pharmacists, Inc. All rights reserved. 1079-2082/04/0602-1242$06.00

Practice Report

Extended stability of iobenguane under simulated clinical conditions

 George H. Hinkle, Jillian V. Dura, Richard S. Morosco and Milap C. Nahata

GEORGE H. HINKLE, M.S., BCNP, FASHP, FAPhA, is Associate Professor of Pharmacy Practice, College of Pharmacy; JILLIAN V. DURA, PHARM.D., is Nuclear Pharmacy Fellow, College of Pharmacy; RICHARD S. MOROSCO is Research Associate, College of Pharmacy; and MILAP C. NAHATA, PHARMD., M.S., is Professor and Chair, Division of Pharmacy Practice, College of Pharmacy, and Professsor of Pediatrics and Internal Medicine, College of Medicine, The Ohio State University, Columbus.

Address correspondence to Mr. Hinkle at the College of Pharmacy, The Ohio State University, 500 West 12th Avenue, Columbus, OH 43210 (hinkle.5{at}osu.edu).


Purpose. The stability of iobenguane sulfate stored at 4–7 °C over 91 days was studied.

Methods. An iobenguane sulfate solution at a concentration of 2.2 mg/mL was prepared in a top-fill i.v. bag using 143 mg of iobenguane sulfate and 65 mL of Sterile Water for Injection, USP. The solution was poured through a 0.22- µm filter assembly for sterilization into 60 1-mL polycarbonate plastic syringes. Each syringe was filled with 0.9 mL of the iobenguane sulfate solution and stored in amber plastic bags at 4–7 °C. The stability of iobenguane sulfate was analyzed using high-performance liquid chromatography immediately after solution preparation and on days 7, 14, 28, 42, 56, 70, and 91. Samples were inspected for chemical purity by observing for particulate formation and color change.

Results. The mean concentration of ioben-guane exceeded 93% of the initial concentration in all samples throughout the 91-day study period. No changes in color or turbidity were observed.

Conclusion. Iobenguane sulfate 2.2 mg/mL was stable for 91 days when stored in polycarbonate syringes at 4–7 °C.

Index terms: Antineoplastic agents; Chromatography, liquid; Color; Concentration; Injections; Iobenguane sulfate; Polycarbonate; Stability; Storage; Syringes; Turbidity

 





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Copyright © 2008 by the American Society of Health-System Pharmacists.