Determination of 2-chloroethanol and ethylene glycol residues in disposable infusion sets
10.19745/j.1003-8868.2024190
- VernacularTitle:一次性使用输液器产品中2-氯乙醇和乙二醇残留量的测定方法研究
- Author:
Ruo-Jin LIU
1
;
Bao-Yu LIU
;
Hui LI
;
Yi FENG
;
Wen-Liang SHAO
Author Information
1. 河北省药品医疗器械检验研究院,石家庄 050227
- Keywords:
2-chloroethanol;
ethylene glycol;
ethylene oxide sterilization;
portable infusion set;
gas chromatography
- From:
Chinese Medical Equipment Journal
2024;45(10):31-36
- CountryChina
- Language:Chinese
-
Abstract:
Objective To propose an effective method for the determination of 2-chloroethanol(ethylene chlorohydrin,ECH)and ethylene glycol(EG)residues in disposable infusion sets sterilized by ethylene oxide(EO).Methods Extraction with the ratio of the mass of the disposable infusion set to the volume of the medium being 0.4 g/mL was carried out with the 8890B gas chromatograph with liquid injection,DB-WAX column and ethanol extraction medium,and quantitative determination of ECH and EG in disposable infusion sets were implemented after extraction at 37℃for 10 h.Results The method proposely was highly specific,and showed high linearity in the range of 1.25-100.00 μg/mL for both ECH and EG.The limits of detection were 0.31 and 0.11 μg/mL for ECH and EG,respectively,and the relative standard deviations(RSD)of the precision of ECH was in the range of 0.24％-2.03％and those of EG was in the range of 0.16％-0.87％.The average recoveries were 95.02％-100.58％for ECH and 99.15％-99.98％for EG.Conclusion The method proposed for the determination of ECH and EG residues gains advantages in easy operation,specificity,detection accuracy and reproducibility,and meets the requirements for the determination of ECH and EG residues in EO-sterilized disposable infusion sets.[Chinese Medical Equipment Journal,2024,45(10):31-36]
