Revision Plan of Spectrometry General Chapters of USP and Enlightenment to the Chinese Pharmacopoeia

Xu Xinyi, Liu Zhen, Hong Xiaoxu

Chinese Pharmaceutical Affairs ›› 2019, Vol. 33 ›› Issue (2) : 202-207.

Chinese Pharmaceutical Affairs ›› 2019, Vol. 33 ›› Issue (2) : 202-207. DOI: 10.16153/j.1002-7777.2019.02.014
Foreign Pharmacy

Revision Plan of Spectrometry General Chapters of USP and Enlightenment to the Chinese Pharmacopoeia

  • Xu Xinyi1, Hong Xiaoxu1, Liu Zhen2
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Abstract

Objective: To provide references for the revision of spectroscopy general chapters of Chinese Pharmacopoeia volume IV 2020 edition. Methods: By reviewing the revision history and future plans of the United States Pharmacopoeia (USP) from 2010 to 2020, the revision purpose and content of spectroscopy general chapters in USP during the last ten years were summarized. The revision plan of the spectroscopy general chapters of Chinese Pharmacopoeia four volumes was discussed. Results: The spectroscopy overview general chapter of USP will be deleted from 2015 to 2020. Spectroscopy general chapters with the same system structure will be developed and corresponding guidelines will also be provided. The relevant qualification, validation and verification guidelines for analytical instruments will be revised. Conclusion: A systematic and holistic revision plan should be established. The structure of spectroscopy general chapters of Chinese Pharmacopoeia four volumes should be standardized. Suitability in the monograph should be improved and advanced methods and techniques should be introduced.

Key words

United States Pharmacopoeia;spectrometry;Chinese Pharmacopoeia;revision

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Xu Xinyi, Liu Zhen, Hong Xiaoxu. Revision Plan of Spectrometry General Chapters of USP and Enlightenment to the Chinese Pharmacopoeia[J]. Chinese Pharmaceutical Affairs, 2019, 33(2): 202-207 https://doi.org/10.16153/j.1002-7777.2019.02.014

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