Establishment and Analysis of the Determination Method of Extractable Tungsten for Prefilled Syringes
10.3870/j.issn.1004-0781.2025.07.007
- VernacularTitle:预灌封注射器钨溶出量测定法制订与解析
- Author:
Chunyue LIU
1
;
Manru ZHANG
;
Yang QIN
;
Xiaowen BO
;
Yong SHEN
;
Lei CHEN
Author Information
1. 山东省医疗器械和药品包装检验研究院,国家药品监督管理局药品包装材料质量控制重点实验室,济南 250101
- Publication Type:Journal Article
- Keywords:
Prefilled syringes;
Tungsten dissolution quantity;
The Pharmacopoeia of the People's Republic of China;
Inductively coupled plasma optical emission spectrometer;
Inductively coupled plasma mass spectrometry
- From:
Herald of Medicine
2025;44(7):1055-1060
- CountryChina
- Language:Chinese
-
Abstract:
Objective To formulate the drug packaging material method standards in the 2025 edition of the Pharmacopoeia of the People's Republic of China(referred to as the"Chinese Pharmacopoeia"),to develop the method for the determination of extractable tungsten for prefilled syringes,and to interpret the content of the method to provide guidance and help for its subsequent implementation.Methods The formulation process of"Determination of Extractable Tungsten for Prefilled Syringes"was described.Combining the current domestic and foreign relevant standards,the extraction conditions of samples were explored and verified,and the determination methods of inductively coupled plasma optical emission spectrometer(ICP-OES)and inductively coupled plasma mass spectrometer(ICP-MS)were verified.Results A method was established for extracting tungsten from glass prefilled syringes utilizing water and 0.01 mol·L-1 sodium hydroxide solution as extraction media,respectively,at 75 ℃ through ultrasound.The dissolution amount of tungsten was determined by inductively coupled plasma opticalemission spectrometry(ICP-OES)and inductively coupled plasma mass spectrometry(ICP-MS).Among them,the extraction using 0.01 mol·L-1 sodium hydroxide solution as the extraction medium is a stricter and acceptable alternative approach.Conclusion According to the quality control requirements of products,corporations can choose the appropriate extraction medium according to the method in this standard for the determination of tungsten dissolution in the prefilled syringes.
