A Comprehensive Review of Quantifications, Profiling, and Regulations of Pharmaceutical Impurities
Dev Prakash Dahiya, Geetanjali Saini, Amit Chaudhary, Bhupendra Singh, Pooja Sharma, Vandana Thakur, Nisha Thakur, Manish Vyas
Journal of Pharmaceutical Research International · pp. 194–222 · Published 28 Dec 2021
10.9734/jpri/2021/v33i62A35200Abstract
In the past few decades impurity profiling has continuously gained the attention of regulatory bodies due to the rise in the number of drugs frequently entering the market. International regulatory agencies like ICH, FDA, Canadian Drug and Health Agency emphasize carrying out impurity profiling of drugs in strict compliance with the regulatory guidelines that have been laid down intending to ensure production of high quality and safe pharmaceutical drugs to serve mankind. Simple impurities can be easily evaluated by conventionally available methods whereas impurities present within complex matrix structure pose significant challenges to the analyst and require a more sophisticated approach. The work has been carried out with great efforts to make the study possible distinctively and comprehensively.
Cited by 3
Manoj Kumar Mandapaka, Veeraswami Boddu · Analytical Chemistry Letters · 2024
Raymond R. Tjandrawinata, Antonius H. Cahyana, Ajeng O. Nugroho · Advances in Pharmacological and Pharmaceutical Sciences · 2024
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