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Published on: June 7, 2024
[Product standard and quality control of sodium hyaluronate]
Qisheng Gu1, Qiong Wang, Ailing Fu
1Shanghai Jingfeng Pharmaceutical Corporation Limited, Shanghai 201908, PR China. qishenggu@163.com
Objective:
To analyze and compare the domestic quality standard and foreign quality standard of sodium hyaluronate (HA), and to expatiate on the critical process monitoring parameters.
Methods:
Different quality standards of HA were compared by translating and sorting, and some experimental data were analyzed as well as the manufacturing practice was elaborated.
Results:
Differences exist in raw materials standard or specifications of products between domestic and foreign, but the basic control points are concordant.
Conclusion:
The company should set up reasonable and controllable quality standard based on quality requirements and related process characteristics so as to assure the safety and effectiveness of the clinical application.
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