Analytical Approaches to Understanding and Qualifying Extraneous Peaks in Impurity Profiling of Drug Products and Active Pharmaceutical Ingredients
| International Journal of Applied Chemistry |
| © 2024 by SSRG - IJAC Journal |
| Volume 11 Issue 2 |
| Year of Publication : 2024 |
| Authors : Kannan Jakkan, Narasimha Naidu Mopidevi |
10.14445/23939133/IJAC-V11I2P103
How to Cite?
Kannan Jakkan, Narasimha Naidu Mopidevi, "Analytical Approaches to Understanding and Qualifying Extraneous Peaks in Impurity Profiling of Drug Products and Active Pharmaceutical Ingredients," SSRG International Journal of Applied Chemistry, vol. 11, no. 2, pp. 14-27, 2024. Crossref, https://doi.org/10.14445/23939133/IJAC-V11I2P103
Abstract:
In chromatography, the presence of extraneous peaks refers to a serious issue, which complicates the further analytical data evaluation. It is an important problem with chromatography that extraneous peaks may appear that give unaccredited errors in analytical results. These ‘overloaded’ regions can be due to various factors like the presence of interfering substances in the sample matrix, the reagents, the chromatographic columns, or the formation of artifacts during the analytical process. The following review explores the potential reason that contributes to the extra peaks and identifies major points including sample preparation, system control, and quality supply products. Among others, it goes a step further in analyzing refined troubleshooting approaches as well as how to avoid the costs associated with these sudden spikes. Otherwise, by recognizing the causative factors of extra humps, the chromatographic measurements could be made more accurate and the peaks more distinctive and clearer, and therefore meet the expectations of analysts. This research work is concerned with the examination of such patterns, their detection, as well as their categorization into qualified or not. Thus, to identify the causes of extraneous peaks we systematically discuss potential sources of these peaks, including sample impurities, reagents contamination, or artificial peaks from instruments. Protein peaks under study are well characterized using Mass spectrometry and spectral analysis to quantify the values for analytical purposes. This work aims to provide, through intensive investigation and strict qualification, more credibility and fewer errors for the chromatographic analysis and, thus, the quality of the derived analytical data.
Keywords:
Chromatography, Extraneous peaks, Drug product, High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC).
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