Chinese Journal of Blood Purification

Chinese Journal of Blood Purification ›› 2022, Vol. 21 ›› Issue (11): 862-864.doi: 10.3969/j.issn.1671-4091.2022.11.016

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A preliminary study on the quality control of chemical raw materials and excipients of concentrates for hemodialysis

YE Xiao-yan, LUO Qing-feng, HUANG Min-ju, QU Ya-nan, HUANG Qi-yu   

  1. Guangdong Medical Devices Quality Surveillance and Test Institute; Key Laboratory for Extracorporeal Circulation Devices, National Medical Products Administration, Guangzhou 510663, China; 2Center for Medical Device Evaluation, National Medical Products Administration, Beijing 100081, China
  • Received:2022-07-05 Revised:2022-09-01 Online:2022-11-11 Published:2022-11-12
  • Contact: 510663 广州，广东省医疗器械质量监督检验所；国家药品监督管理局体外循环器械重点实验室 E-mail:107781964@qq.com

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Abstract: By comparing the related international standards, industry standards and pharmacopoeia of chemical raw materials and excipients of concentrates for hemodialysis, the quality control requirements of chemical raw materials and excipients for hemodialysis concentrates were studied according to the current regulations and policies. At the same time, the additional requirements of raw materials and excipients for hemodialysis were described, for reference of the professionals in related fields.

Key words: Concentrates for hemodialysis, Chemical raw materials and excipients, Sodium bicarbonate, Magnesium chloride

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