GB/T 43778-2024
Determination of styrene and 2-chloroethanol in cell culture fluid by gas chromatography-mass spectrometry (GC-MS) method (English Version)
- Standard No.
- GB/T 43778-2024
- Language
- Chinese, Available in English version
- Release Date
- 2024
- Published By
- General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China CN / GB
- Latest
- GB/T 43778-2024
- Introduction
Professional interpretation of the National Standard of the People's Republic of China GB/T 43778—2024
1. Background of standard formulation and analysis of technological evolution
This standard was proposed by the National Technical Committee for Standardization of Biochemical Testing to standardize the determination of styrene and 2-chloroethanol in cell culture medium. With the rapid development of biopharmaceuticals and cell culture technology, the demand for accurate detection of trace substances is increasing. GC-MS method has become an ideal choice in this field with its high sensitivity and high resolution.
2. Comparison of standard frameworks
Standard dimensions GB/T 43778—2024 Comparison with international standards Scope of application Detection of free styrene and 2-chloroethanol in cell culture medium Consistent with ISO standards, applicable to biological products and environmental monitoring Principle of the method GC-MS method, internal standard method for quantification In line with international general testing procedures Reagent requirements Chromatographic pure reagents, first-grade water Align with the United States Pharmacopoeia (USP) and the European Pharmacopoeia (PhEur) 3. Implementation recommendations
Laboratory preparation:Ensure that a GC-MS instrument and an automatic headspace sampler are equipped, and the equipment is calibrated regularly to ensure detection accuracy.
Operator training:Provide detailed standard interpretation and practical operation training to technical personnel, focusing on the application of the internal standard method and instrument maintenance.
Quality control:Establish an internal standard curve, regularly verify the detection limit and precision, and ensure data reliability.
GB/T 43778-2024 Referenced Document
- GB/T 6682 Water for analytical laboratory use.Specification and test methods
GB/T 43778-2024 history
- 2024 GB/T 43778-2024 Determination of styrene and 2-chloroethanol in cell culture fluid by gas chromatography-mass spectrometry (GC-MS) method
