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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 ,
  • HUANG Qi-Yu
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  • 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 date: 2022-07-05

  Revised date: 2022-09-01

  Online published: 2022-11-12

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.

Cite this article

YE Xiao-Yan , LUO Qing-Feng , HUANG Min-Ju , HUANG Qi-Yu . A preliminary study on the quality control of chemical raw materials and excipients of concentrates for hemodialysis[J]. Chinese Journal of Blood Purification, 2022 , 21(11) : 862 -864 . DOI: 10.3969/j.issn.1671-4091.2022.11.016

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