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A range of tools and techniques utilized in investigations are discussed with examples. While not exhaustive, it includes pivotal analytical methods such as Scanning Electron Microscopy (SEM), X-ray diffraction (XRD), Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), spectroscopy techniques (such as infrared, Raman, NMR, UV-visible, mass spectrometry (MS), and others), and advanced particle size and rheology analyzers. The latest technologies—machine learning (ML) and artificial intelligence (AI)—can potentially improve investigation precision and efficiency. It is essential to integrate multiple complementary techniques to get to a comprehensive and accurate investigative outcome. Approaches such as Process Modeling and digital twins are also relevant in contemporary pharmaceutical investigations.

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Analytical Tools for Investigation and Generation of Supporting Evidence

  • 章节

  • 发表日期：

    2025年

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  • Ajay Babu Pazhayattil,
  • Sanjay Sharma

摘要

A range of tools and techniques utilized in investigations are discussed with examples. While not exhaustive, it includes pivotal analytical methods such as Scanning Electron Microscopy (SEM), X-ray diffraction (XRD), Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), spectroscopy techniques (such as infrared, Raman, NMR, UV-visible, mass spectrometry (MS), and others), and advanced particle size and rheology analyzers. The latest technologies—machine learning (ML) and artificial intelligence (AI)—can potentially improve investigation precision and efficiency. It is essential to integrate multiple complementary techniques to get to a comprehensive and accurate investigative outcome. Approaches such as Process Modeling and digital twins are also relevant in contemporary pharmaceutical investigations.