Vol 6, No 2 (2024)

Pharmaceutical Impurity Profiling: Strategies and Techniques

Author: Priya Reddy

Abstract: Impurity profiling is a critical aspect of pharmaceutical analysis, ensuring the safety, efficacy, and quality of pharmaceutical products. This paper explores various strategies and techniques used in impurity profiling, focusing on analytical methods such as High-Performance Liquid Chromatography (HPLC), Mass Spectrometry (MS), and Nuclear Magnetic Resonance (NMR) spectroscopy. The paper discusses the significance of impurity profiling in drug development, regulatory requirements, and quality control. Additionally, the advancements in analytical techniques and their impact on improving impurity profiling are examined. The challenges and future prospects of impurity profiling in pharmaceutical analysis are also explored.

Keywords: Impurity Profiling, High-Performance Liquid Chromatography (HPLC), Mass Spectrometry (MS), Nuclear Magnetic Resonance (NMR) Spectroscopy, Quality Control

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