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  6. <Blog Introduction> Explanation of the Guidelines for Elemental Impurities and the 18th Revision of the Japanese Pharmacopoeia

<Blog Introduction> Explanation of the Guidelines for Elemental Impurities and the 18th Revision of the Japanese Pharmacopoeia

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last updated:Jan 21, 2025

サーモフィッシャーサイエンティフィック株式会社/Thermo Fisher Scientific K.K.
サーモフィッシャーサイエンティフィック株式会社/Thermo Fisher Scientific K.K.
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Detailed management of elemental impurities for the Elemental Impurities Guideline (ICH Q3D) and the 18th Revision of the Japanese Pharmacopoeia (JP 18)!

This article provides a detailed explanation of ICH Q3D and the 18th edition of the Japanese Pharmacopoeia (JP18), as well as an introduction to appropriate analytical methods and analytical instruments. This is a must-read article for those who fall into the following categories: - Those involved in quality control of pharmaceuticals in the pharmaceutical industry - Those looking for workflows for quality assurance - Those who want to gain a deeper understanding of the Elemental Impurities Guidelines (ICH Q3D) - Those who want to know what the 18th edition of the Japanese Pharmacopoeia (JP18) is.

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<Blog Introduction> Explanation of the Guidelines for Elemental Impurities and the 18th Revision of the Japanese Pharmacopoeia

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サーモフィッシャーサイエンティフィック株式会社/Thermo

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Thermo Fisher Scientific K.K., the Japanese subsidiary of Thermo Fisher Scientific Incorporated, is a sales company for comprehensive system analysis instruments, bio-related equipment, and research reagents. In Japan, it has bases in Yokohama, Tokyo, Osaka, Fukuoka, and Nagoya, handling various analytical instruments including mass spectrometers, various bio-related equipment, measuring instruments, medical devices, lab software, and research reagents.

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