摘要
Plastic equipment used in cell culture processes contains styrene residues and 2-chloroethanol, a byproduct of ethylene oxide sterilization. Both compounds can have long-term effects on the quality and safety of the cells in plastic equipment. GB/T 43778-2024, which establishes a gas chromatography-mass spectrometry(GC-MS) method for the simultaneous detection of st yrene and 2-chloroethanol in cell culture media, includes several technical requirements that need to be thoroughly interpreted. This paper provides a detailed explanation of the internal standard calibration method used for detecting styrene and 2-chloroethanol, covering the overall framework and innovation aspects of the standard. Additionally, it elucidates the principles and rationale of each step, including sample processing, detection parameters, preparation of standard solutions, and the determination of detection and quantification limits, to assist testing technical staff in applying the method effectively.
基金
funded by National Key Research and Development Project (No. 2018YFA0108403)
Provincial University Basic Research Operating Expenses Project (No. 21SBYB08)
