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  6. Certified Reference Material (CRM) for Elemental Impurity Analysis of Pharmaceuticals

Certified Reference Material (CRM) for Elemental Impurity Analysis of Pharmaceuticals

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last updated:Jan 17, 2023

メルク株式会社ライフサイエンス(シグマ アルドリッチ ジャパン合同会社)
メルク株式会社ライフサイエンス(シグマ アルドリッチ ジャパン合同会社)
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Manufactured in facilities accredited to ISO/IEC 17025 and ISO 17034 according to the ICH Q3D guidelines.

The "Certified Reference Material (CRM) for Elemental Impurity Analysis of Pharmaceuticals" is a mixed solution prepared at concentrations that correspond to the permissible daily exposure (PDE) values outlined in the ICH Q3D guidelines. It ensures the safety of your pharmaceuticals by adhering to the elemental concentration limits for oral, non-oral, and inhalation routes. With the elimination of human preparation errors, it allows for more accurate analysis and reproducibility. 【Features】 ■ Manufactured in facilities accredited to ISO/IEC 17025 and ISO 17034 ■ Improved stability through innovative container design ■ Pre-prepared mixed solution *For more details, please refer to the PDF document or feel free to contact us.

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医薬品の元素不純物分析対応認証標準物質(CRM).png

Certified Reference Material (CRM) for Elemental Impurity Analysis of Pharmaceuticals

医薬品の元素不純物分析対応認証標準物質(CRM).png
医薬品の元素不純物分析対応認証標準物質(CRM).png
  • Related Link - https://www.sigmaaldrich.com/JP/ja/products/analyt…
  • Special site - Product/service details - https://pr.mono.ipros.com/milliporenihon/product/

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【Other Features】 ■ Traceable to at least two references (NIST, BAM) ■ Information on appropriate uncertainty, expiration dates, and storage ■ Comprehensive documentation in accordance with ISO Guide 31 ■ Ensures reliability through the use of certified reference materials ■ Utilizes special fluoropolymer bottles ■ Enhances stability by sealing in a highly airtight aluminum bag ■ Significantly reduces preparation time and costs ■ Eliminates human preparation errors for more accurate analysis and reproducibility *For more details, please refer to the PDF document or feel free to contact us.

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Certified Reference Material (CRM) for Element Impurity Analysis of Pharmaceuticals

Certified Reference Material (CRM) for Element Impurity Analysis of Pharmaceuticals

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メルク株式会社ライフサイエンス(シグマ

メルク株式会社ライフサイエンス(シグマ アルドリッチ ジャパン合同会社)

Testing, Analysis and Measurement

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From research and development of pharmaceuticals to manufacturing and diagnostics, Merck is working to solve various challenges in life sciences in collaboration with the global science community. Merck's products include over 300,000 items, ranging from laboratory pure and ultra-pure water systems to gene editing tools for drug manufacturing, antibodies, cell lines, and end-to-end systems. To realize promising research more quickly and safely, we closely collaborate with customers in academia, the biotechnology industry, and the pharmaceutical industry. Please feel free to contact us for inquiries about our products or if you are interested in raw material supply. Here is the Merck ultra-pure and pure water systems webpage → https://www.merckmillipore.com/LW Here is the Merck life science reagents, raw materials, and analysis webpage → https://www.sigmaaldrich.com/JP/ja

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