CHROMATOGRAPHIC METHOD FOR THE ANALYSIS OF BOTH IN PROCESS AND FINISHED SEVOFLURANE

摘要

A method in which organic matter found in a crude sevoflurane may be separated, identified, and quantified using a CARBOWAXTM (polyethylene glyco l) capillary gas chromatographic column or an alkyl polysiloxane capillary gas chromatographic column. Also provided is a process control method for the production of sevoflurane, wherein the content of a particular component in one of the following steps is determined, and in that, assuming this as a variable, the treatment condition of the step is adjusted: 1) a step of extracting, or cooling to form two layers, and/or distilling a mixture of crude sevoflurane and hydrogen fluoride (HF) in order to isolate the majorit y of the sevoflurane and 2) an optional step of purifying the crude sevofluran e and 3) a step of distilling crude sevoflurane. Also provided is a method for determining the impurity level of a purified sevoflurane that is acceptable for use in human/animal anesthesia.