Study on the Migration of Residual Styrene to Moxifloxacin Hydrochloride and Sodium Chloride Injection from Five-layer Co-extrusion Bags / 中国药师

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.