A Brief Review on Genotoxic impurities in Pharmaceuticals

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...

Full description

Saved in:
Bibliographic Details
Published inAsian Journal of Pharmaceutical Research Vol. 11; no. 3; pp. 187 - 193
Main Authors Patel, Ashok B., Asnani, Ashish H., Vyas, Amitkumar J., Patel, Nilesh K., Patel, Ajay I., Lumbhani, Arvind N.
Format Journal Article
LanguageEnglish
Published Raipur Athena Information Solutions Pvt. Ltd 01.09.2021
Subjects
Carcinogens
Classification
Drug dosages
International conferences
Pharmaceutical sciences
Pharmaceuticals
Pharmacy
Process controls
India
Online AccessGet full text

Cover

More Information
Summary: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.
ISSN:2231-5683
2231-5691
DOI:10.52711/2231-5691.2021.00034