GU Qisheng 1,2 , WANG Qiong 1 , FU Ailing 1
  • 1Shanghai Jingfeng Pharmaceutical Corporation Limited, Shanghai, 201908, P.R.China;;
  • 2Shanghai Qisheng Institution of Biomaterials and Technology.;
Sodium hyaluronate; Raw material standard; Specification of product; Quality control
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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.

Citation： GU Qisheng,WANG Qiong,FU Ailing. PRODUCT STANDARD AND QUALITY CONTROL OF SODIUM HYALURONATE. Chinese Journal of Reparative and Reconstructive Surgery, 2011, 25(9): 1130-1135. doi: Copy