Sevoflurane: Impurities and Stability Testing

We report an impurities and stability testing study on two different batches of three different commercial formulations of sevoflurane, the widely used fluorinated inhalation anesthetic agent. Our analyses focused on identifying the starting presence of volatile impurities as well as the formation of degradants after storage also under accelerated ageing conditions. We found that the analyzed samples show differences in quality and quantity of impurities as a likely consequence of the different manufacturing processes. Impurities may vary from one batch to the other of a given formulation, but in all case they are well below limits specified by regulatory agencies for clinical use, the content in sevoflurane being always > 99.99%. Fluoride anion concentrations were below 0.1 mg/L in all analyzed samples, consistent with no degradation occurring in the examined timeframe.