Sevoflurane: are there differences in products?

Abstract

Sevoflurane is currently available in the United States from two manufacturers: Ultane (Abbott Laboratories, Inc.) and a generic product, Sevoflurane Inhalation Anesthetic (Baxter Healthcare Corp.). These products are rated therapeutically equivalent by the Food and Drug Administration, but there are some differences. Ultane is made in a single-step synthetic process and generic sevoflurane is manufactured using a three-step process. Ultane contains >300 ppm water and generic sevoflurane contains < or =130 ppm water. Ultane is supplied in a plastic polyethylene naphthalate polymer bottle, while generic sevoflurane is supplied in lacquer-lined aluminum bottles. The manufacturing processes and impurities, sevoflurane degradation resulting from Lewis acid reactions, and suitability of nonglass containers for sevoflurane are discussed.