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| 美国药典43版近红外通则内容最新变化浅析 |
| A Review on the latest update and revision of the Near-infrared Spectroscopy Chapter in the United States Pharmacopeia (43 version) |
| 投稿时间：2020-10-15 修订日期：2021-04-28 |
| DOI： |
| 中文关键词: 美国药典43版 通则 近红外光谱分析技术 修订 |
| 英文关键词: United States Pharmacopeia (43 version) general chapter near-infrared spectroscopy revision |
| 基金项目: |
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| 中文摘要: |
| 目的：跟踪美国药典检验检测技术最新发展和动态，为国内近红外光谱技术在制药领域的监管和应用提供借鉴和参考。方法：通过文献检索和新旧版美国药典比对，归纳总结美国药典43版中近红外光谱技术通则有关章节的增修订情况。结果：与42版相比，美国药典43版近红外通则内容进行了较大规模的修订和更新。新增了通则<856>，同时将原有的通则<1119>修订并重命名为<1856>近红外光谱技术的理论和应用实践。通则<856>侧重近红外光谱仪器的确认和方法的验证，通则<1856>侧重近红外光谱技术的基础理论和实践经验。结论：美国药典43版近红外通则内容的修订，不仅为使用近红外光谱技术的制药企业和药品检验机构在满足ISO17025关于仪器确认和方法验证相关要求方面提供了最新的技术指南和依据，还明确了该技术作为替代方法应用于各论时需要满足的最低标准，进一步提高了通则内容的实用性和可操作性，为药品生产和监管领域对近红外光谱技术的应用和相应的质量管理体系建设提供了很好的依据和参考，同时对各国药典相关内容的增修订也有很高的借鉴作用。 |
| 英文摘要: |
| Objective: To provide references for the supervision and application of near-infrared spectroscopy (NIRS) in the domestic pharmaceutical field. Method: By comparison between the latest and previous version of the United States Pharmacopeia (USP) and literature review, the changes on the general chapter Near-Infrared Spectroscopy in the USP (43 version) were highlighted and summarized. Results: Compared with the 42 version, fairly comprehensive update and revision were adopted in the 43 version in terms of NIRS General Chapters. A new general chapter titled <856>Near-Infrared Spectroscopy was included, and the general chapter <1119> was revised and renamed as <1856> Near-Infrared Spectroscopy——theory and practice in the 43 version. The chapter <856>focuses on qualification criteria for instrument as well as the acceptable procedure validation criteria. The chapter <1856> provides the theory and practices of NIRS. Conclusion: The updated chapters on NIRS in the USP (43 version) provide the regulatory authorities and quality laboratories not only the reference and guidance for how to meeting ISO 17025 requirements for the instrument qualification and analytical method validation related with NIRS, it also explicitly texts the minimum standard to demonstrate the suitability for use when an NIRS spectroscopic procedure is intended for use as an alternative to the monograph procedure. In addition, the updated chapters in USP 43 could provide valuable insights and knowledge for other world pharmacopoeias into further revision with this topic in the future. |
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