Overview on Impurity Profiling

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Published: Jan 11, 2023
Keywords:
Impurities Impurity Profiling Analytical Methods ICH Guidelines

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Prabakaran.C
Saveetha College of Pharmacy, Saveetha Institute of Medical and Technical Sciences,Saveetha University,Chennai,India
Vignesh.R
Saveetha College of Pharmacy, Saveetha Institute of Medical and Technical Sciences,Saveetha University,Chennai,India
Yuvaraj M,Ramya G
Saveetha College of Pharmacy, Saveetha Institute of Medical and Technical Sciences,Saveetha University,Chennai,India
Reka S
Assistant Professor Department of Pharmaceutical Analysis Saveetha College of Pharmacy,Saveetha Institute of Medical And Technical Science,Saveetha Universty,Chennai,India

Abstract

The current scenario in the field of Pharmaceutical analysis have enormously focusing of the Impurity profiling of newer drug substances and their characterization.Impurities can be stated as unwanted substances which may comes along with the main pharmaceutiucal product by several sources.Each and every API,contains impurities which lessens the quality of the original product.Impurity profiling is the way of detecting,identifying and quantitatively determining all the forms of impurities both identified and unidentified one by using a group of analytical methods.The Present review focuses on the types of pharmaceutical impurities,their characterization by sophisticated instruments with special emphasization on regulatory guidelines.

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How to Cite
Prabakaran.C, Vignesh.R, Yuvaraj M,Ramya G, & Reka S. (2023). Overview on Impurity Profiling. Journal of Coastal Life Medicine, 11(1), 1431–1441. Retrieved from https://www.jclmm.com/index.php/journal/article/view/538
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Vol. 11: Number 1, 2023
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Articles

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