Determination of Plasticizer DEHP Released from Medical Injection Equipment
10.3969/j.issn.1671-7104.2015.06.017
- VernacularTitle:医用注射器具中DEHP增塑剂溶出量测定
- Author:
Jian ZHENG
1
;
Minzhu WANG
;
Anyan WANG
;
Pinghua XU
;
Yin HAN
;
Yan WEN
;
Li ZHANG
Author Information
1. 国家食品药品监督管理局杭州医疗器械质量监督检验中心
- Keywords:
injection equipment;
gas chromatography tandem mass spectrometry;
DEHP;
plasticizer
- From:
Chinese Journal of Medical Instrumentation
2015;(6):451-453
- CountryChina
- Language:Chinese
-
Abstract:
To established an effective GC-MS /MS method for the contents determination of the residual DEHP in injection equipment, and investigate the effect of the pretreatment on the measurement. To simulate the clinical conditions of use, under the condition of 37oC balance extraction, extract liquor by chloroform extraction, then the extract folowed by analysis of GC-MS /MS. The method was simple, rapid, sensitive and accurate. The limits of quantitation( LOQ, S/N = 5) of cyclohexanone was 0.075mg/mL, The spiked average recoveries ranged from 92% to 98%.The relative standard deviations( RSDs) of the method ranged from 1.01% to 1.61%, The method was simple, fast,sensitive and accurate,and may serve as a mass control method for residual DEHP in injection equipment.
