Thermal degradation of injectable epinephrine.
The degradation of epinephrine in USP injectable cartridges was investigated under different heating conditions. Epinephrine (EPI) and EPI sulfonic acid (EPI-SA) levels in 1:10,000 (0.1 mg/mL) EPI injectable solutions subjected to either cyclical (65 degrees C for 8 hr/d for 4 to 12 weeks) or constant (65 degrees C for 7 days) heating were determined using high-pressure liquid chromatography with diode array and electrochemical detection. Constant (169 total hours of heat exposure) heating resulted in complete degradation of both compounds and dark brown discoloration of the solution. Cyclical heating (672 total hours of heat exposure) resulted in a 31% reduction in EPI concentration and a 225% increase in EPI-SA concentration with no discoloration of the solution. In laboratory-prepared solutions, the degradation of EPI and the formation of EPI-SA was found to be dependent on sodium metabisulfite concentration and the duration of cyclical heating. These results indicate that the thermal stability of EPI and the formation of EPI-SA depends on the method of heat exposure and the amount of bisulfite present in the solution.
Church
W H
WH
Department of Chemistry, East Carolina University, Greenville, NC 27858.
Hu
S S
SS
Henry
A J
AJ
D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D004837:Epinephrine / Q000737:chemistry*; D006358:Hot Temperature; D012996:Solutions; D013447:Sulfites / Q000494:pharmacology; D013997:Time Factors
D012996:Solutions; D013447:Sulfites; C005200:sodium metabisulfite; D004837:Epinephrine