Stability of sterile aqueous lidocaine hydrochloride and epinephrine injections submitted by U.S. hospitals

Abstract

The stability of lidocaine hydrochloride and epinephrine injections that had been stored in hospital pharmacies across the United States was studied.

Through a voluntary drug stability program, the Food and Drug Administration selected 220 samples (representing four manufacturers) from hospital pharmacies representing an adequate cross section of the country. The samples were analyzed for strength, identification, pH, and physical condition.

Six samples failed to meet USP requirements for strength of epinephrine, but all six of these samples had passed the expiration dates. Of the 62 samples that were analyzed for the presence of the d-isomer of epinephrine, approximately 95% had less than 5% d-isomer present. Only one sample had greater than 10% d-isomer present, and this sample had a low epinephrine content (26%) and had passed the expiration date.

Lidocaine hydrochloride and epinephrine injections appear to be stable after storage under actual marketplace conditions.

Anesthetics, local, Concentration, Contamination, Control, quality, Epinephrine, Expiration dates, Hydrogen ion concentration, Injections, Isomers, Lidocaine hydrochloride, Pharmacopeial standards, Stability, Storage, Sympathomimetic agents