Advances in Green Analytical Techniques for Impurity Profiling in Pharmaceuticals

ABSTRACT

This study provides an overview of the green analytical methods in pharmaceutical impurity profiling with focus on regulatory compliance, effectiveness, and environmental impact. We address recent trends in spectroscopic approaches such as Near-Infrared (NIR), Raman spectroscopy, Capillary Electrophoresis (CE), Green Liquid Chromatography (GLC) and Supercritical Fluid Chromatography (SFC). Analyses of the principles of green chemistry are done through avenues including energy efficiency, minimization of wastes generated, as well as the use of safer solvents. The review is based on state-of-the-art sample preparation strategies: miniaturized procedures and SPME. We also address the drawbacks, that is, sensitivity problems and legal restrictions, that halt the wider spread of these techniques. The future perspectives are related to the application of machine learning and artificial intelligence in technique development. This article aims at providing quality control specialists and pharmaceutical researchers with an overview of the latest green analytical techniques, their applications, pitfalls, and promises towards making impurity profiling more sustainable. Using case studies and comparative analysis, we demonstrate how such approaches can be useful in pharmaceutical quality assurance and control.

KEYWORDS

• Chromatography
• Green Analytical Chemistry
• Pharmaceutical Impurity Profiling
• Sustainable Methods
• Spectroscopy
• Sample Preparation
• Regulatory Compliance

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• DOI10.5530/jyp.20250075Copy

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