Study on the Migration of Residual Styrene to Moxifloxacin Hydrochloride and Sodium Chloride Injection from Five-layer Co-extrusion Bags
- VernacularTitle:五层共挤输液袋中残留苯乙烯在盐酸莫西沙星氯化钠注射液中迁移的检测研究
- Author:
Xin YANG
1
;
Yifan CHENG
;
Tao QIU
;
Yanan ZHAO
Author Information
1. 陕西省食品药品检验所 西安710065
- Keywords:
Five-layer co-extrusion infusion bag;
Styrene;
Moxifloxacin hydrochloride;
GC-MS
- From:
China Pharmacist
2017;20(11):1969-1971
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a monitoring method for the detection of styrene monomer migration to moxifloxacin hydrochlo-ride and sodium chloride injection. Methods:A GC-MS method with a DB-5MS (30 m×0.25 mm,0.25 μm) column was used to determine styrene by the manner of large volume headspace purge-trap. Results:The linearity of styrene was good within the range of 0.009 1-0.364 μg·ml-1(r=0.999 9),and the average recovery of styrene in moxifloxacin hydrochloride and sodium chloride injec-tion was 99.4%(RSD=1.1%,n=9). After the detection of several batches of samples,the amount of styrene migration was all be-low the detection limit.Conclusion:The method can be used to measure the migration of styrene remained in five-layer co-extrusion in-fusion bags to moxifloxacin hydrochloride and sodium chloride injection.
