Establishment and Analysis of the Method for Determining the Leaching Amount of Bisphenol A Monomer in Metal Coatings
10.3870/j.issn.1004-0781.2025.11.007
- VernacularTitle:金属涂料涂层中双酚A单体的浸出量方法制订与解析
- Author:
Weiming GU
1
;
Yuan LIU
1
;
Fangfang ZHANG
1
Author Information
1. 上海市食品药品包装材料测试所,上海 201203
- Publication Type:Journal Article
- Keywords:
Metal coatings;
Bisphenol A;
High performance liquid chromatography;
High performance liquid chromatography-tandem mass spectrometry;
Leaching amount
- From:
Herald of Medicine
2025;44(11):1768-1772
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish methods for determining the leaching amount of bisphenol A monomer in metal coatings as one of the guidelines on metal materials and containers for drug packaging in the 2025 edition of the Pharmacopoeia of the People's Republic of China.Methods The formulation process of the method for determining the leaching amount of bisphenol A monomer in metal coatings was explained.Through the verification of the two analysis methods,the scientific and rational aspects of the method were examined,and the determination results of the leaching amount of bisphenol A monomer by high performance liquid chromatography(HPLC)and high performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS)were compared.Results HPLC was suitable for the detection of general routine samples and can obtain experimental results more efficiently;HPLC-MS/MS has higher sensitivity and selectivity,and is more suitable for the detection of trace bisphenol A in samples with complex substrates.Conclusion Enterprises and scientific research institutions can choose their own determination methods and formulate reasonable limits according to the actual situation of products and the configuration needs of daily testing instruments.
