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Abstract

The detection and characterization of impurities in pharmaceuticals are pivotal aspects of ensuring the safety, efficacy, and quality of drug products. This review provides a comprehensive overview of the analytical techniques employed in the identification and quantification of impurities at various stages of pharmaceutical development, manufacturing, and quality control. Chromatographic methods, including High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC), are foundational for their ability to separate complex mixtures. Mass spectrometry (MS) and Nuclear Magnetic Resonance (NMR) spectroscopy offer high sensitivity and structural insights crucial for impurity characterization. The integration of these techniques, such as in Liquid Chromatography-Mass Spectrometry (LC-MS) and Liquid Chromatography-Nuclear Magnetic Resonance (LC-NMR), provides a synergistic approach to impurity analysis. Advanced hyphenated techniques enhance specificity and accuracy, allowing for real-time monitoring and dynamic adjustments during analysis. Challenges in chiral separation, degradation product analysis, and method validation are addressed through the sophistication of these methodologies. The review underscores the significance of data analysis and validation processes, ensuring the reliability of results in compliance with stringent regulatory standards. Overall, the continuous evolution and integration of analytical techniques play a pivotal role in shaping the future of pharmaceutical research, development, and quality assurance, emphasizing the commitment to producing pharmaceuticals of the highest quality and safety standards.

Keywords

Impurities, Hyphenated Techniques, Active Pharmaceutical Ingredients, Chromatography, Analytical Technique, Detection

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Sagar R. Pagade
Corresponding author

Department of Pharmaceutics , Ashokrao Mane Institute of Pharmacy, Ambap-416112, India

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Sahil Agrawal
Co-author

Department of Pharmaceutics , Ashokrao Mane Institute of Pharmacy, Ambap-416112, India

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Prathmesh Shejal
Co-author

Department of Pharmaceutics , Ashokrao Mane Institute of Pharmacy, Ambap-416112, India

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Pranjal Chougule
Co-author

Department of Pharmaceutics , Ashokrao Mane Institute of Pharmacy, Ambap-416112, India

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Nilesh Chougule
Co-author

Department of Pharmaceutics , Ashokrao Mane Institute of Pharmacy, Ambap-416112, India

Sagar Pagade*, Sahil Agrawal, Prathmesh Shejal, Pranjal Chougule, Nilesh Chougule, Detection Of Impurities: A Review On Advance In Impurities Detection And Characterization In Pharmaceuticals By Analytical Techniques, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 12, 860-879. https://doi.org/10.5281/zenodo.10433875

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