Sevoflurane: are there differences in products?
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.
Baker
Max T
MT
Department of Anesthesia, University of Iowa, Iowa City, Iowa 52242, USA. max-baker@uiowa.edu
D018685:Anesthetics, Inhalation / Q000737:chemistry* / Q000493:pharmacokinetics* / Q000592:standards; D004345:Drug Industry / Q000592:standards; D004349:Drug Packaging / Q000379:methods / Q000592:standards; D008738:Methyl Ethers / Q000737:chemistry* / Q000493:pharmacokinetics* / Q000592:standards; D000077149:Sevoflurane
D018685:Anesthetics, Inhalation; D008738:Methyl Ethers; D000077149:Sevoflurane