Author(s): Ashok B. Patel, Ashish H. Asnani, Amitkumar J. Vyas, Nilesh K. Patel, Ajay I. Patel, Arvind N. Lumbhani


DOI: 10.52711/2231-5691.2021.00034   

Address: Dr. Ashok B. Patel1, Ashish H. Asnani1*, Dr. Amitkumar J. Vyas1, Dr. Nilesh K. Patel1, Dr. Ajay I. Patel1, Dr. Arvind N. Lumbhani2
1Department of Pharmaceutical Quality Assurance, B.K. Mody Government Pharmacy College Polytechnic Campus, Near Aji dem, Bhavnagar Road, Rajkot - 360003 Gujarat, India.
2Gyanmanjari Pharmacy College, Survey No. 30, Sidsar Road Near Iscon Eleven, Bhavnagar – 364001 Gujarat, India.
*Corresponding Author

Published In:   Volume - 11,      Issue - 3,     Year - 2021

Genotoxic impurities (GTIs) in pharmaceuticals are increasing concern to pharmaceutical industries due to their potential for human carcinogenicity. The literature currently lacks the Guidance for the analytical determination of diverse classes of GTIs. This review article provides brief information regarding Genotoxic impurity (GTI), its sources, their classification, and existing regulatory approaches to control Genotoxic impurities in Pharmaceuticals, also information regarding different types of GTI and examples of each class. It is very difficult for researchers to detect GTI at Trace level so the detection method is also given in the chart, almost all the GTI are Mutagenic but as shown in Nitrosamines it is Mutagenic and its carcinogenicity is also proved but there are no such strong evidence and literature which shows genotoxicity. So, it is included as Mutagenic & carcinogenic. Different Control strategies to control Genotoxicity are also discussed.

Cite this article:
Ashok B. Patel, Ashish H. Asnani, Amitkumar J. Vyas, Nilesh K. Patel, Ajay I. Patel, Arvind N. Lumbhani. A Brief Review on Genotoxic impurities in Pharmaceuticals. Asian Journal of Pharmaceutical Research. 2021; 11(3):187-3. doi: 10.52711/2231-5691.2021.00034

Ashok B. Patel, Ashish H. Asnani, Amitkumar J. Vyas, Nilesh K. Patel, Ajay I. Patel, Arvind N. Lumbhani. A Brief Review on Genotoxic impurities in Pharmaceuticals. Asian Journal of Pharmaceutical Research. 2021; 11(3):187-3. doi: 10.52711/2231-5691.2021.00034   Available on:

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