title: [Determination of residual cyclohexanone in disposable infusion set by gas chromatography].
abstract: An effective GC method was established for contents determination of the residual solvent of cyclohexanone in infusion sets for single use. The cyclohexanone in infusion sets for single use products were extracted with circular pump, using ethylalcohol as the extraction solven, then the extract followed by analysis of gas chromatography-tandem mass spectrometry. The method was simple, rapid, sensitive and accurate, Cyclohexanone showed good linearity in the range of (5.5-190.9) μg/mL, the correlation coefficient was 0.999 0, the detection limit (S/N = 3) was 0.133 μg/mL and limits of quantitation (S/N = 10) was 1.33 μg/mL. The spiked average recoveries ranged from 98% to 99%. The relative standard deviations (RSDs) of the method ranged from 1.03% to 1.98%. The method was simple, fast, sensitive and accurate, and may serve as a mass control method for residual cyclohexanone in disposable infusion sets for single use.
authors.affiliation: Medical Device Supervising and Testing Center of Hangzhou, State Food and Drug Administration, Hangzhou. fancyzl11@163.com
authors.forename: Li
authors.initials: L
authors.lastname: Zhang
authors.forename: Yan
authors.initials: Y
authors.lastname: Wen
authors.forename: Tao
authors.initials: T
authors.lastname: He
authors.forename: Minzhu
authors.initials: M
authors.lastname: Wang
authors.forename: Pinghua
authors.initials: P
authors.lastname: Xu
mesh_terms: D003512:Cyclohexanones / Q000032:analysis*; D004209:Disposable Equipment / Q000592:standards*; D008401:Gas Chromatography-Mass Spectrometry; D012997:Solvents / Q000032:analysis
chemical_list: D003512:Cyclohexanones; D012997:Solvents; C036468:cyclohexanone