2024 Volume 13 Issue 2
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Pharmaceutical Impurities and Their Regulatory Aspects with a Special Focus on Genotoxic Impurities


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  1. Department of Regulatory Affairs, Shri Vishnu College of Pharmacy, Bhimavaram, West Godavari (Dt), Andhra Pradesh, India.
  2. Department of Pharmacy, Vignan Pharmacy College, Vadlamudi, Guntur (Dt.), Andhra Pradesh, India.
Abstract

Drug impurity profile studies have changed significantly during the past ten years, as demonstrated by pharmacopeia and regulatory standards. This review article aims to give viewers a thorough understanding of the numerous facts of impurity profiling in relation to regulatory criteria. Comprehensive information on residual solvents, water impurities, elemental impurities, carcinogenicity and an overview of the most critical components of genotoxic contaminants. To ensure the drug products fulfill the minimal acceptable quality standards and a number of pharmacopoeias have created monographs. ICH, EMEA, USFDA and European Pharmacopeia recommendations are just a few of the regulatory bodies that offer rules to reduce the amount of contaminants in medications. In order to prevent impurities, industry, research and development sectors widely employ different spectrum analyses including HPLC, LC/MS and GC/MS. It involves the recall of medications because of these contaminants. The significance of understanding genotoxic impurities as a crucial element of the impurity profile in medications is emphasized in this abstract.


How to cite this article
Vancouver
Kalidindi VR, Somalanka BM, Seethamraju SM, Nori LP. Pharmaceutical Impurities and Their Regulatory Aspects with a Special Focus on Genotoxic Impurities. Int J Pharm Res Allied Sci. 2024;13(2):1-15. https://doi.org/10.51847/kEAkHOrcWf
APA
Kalidindi, V. R., Somalanka, B. M., Seethamraju, S. M., & Nori, L. P. (2024). Pharmaceutical Impurities and Their Regulatory Aspects with a Special Focus on Genotoxic Impurities. International Journal of Pharmaceutical Research and Allied Sciences, 13(2), 1-15. https://doi.org/10.51847/kEAkHOrcWf
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