Major Analytical Problems in Current Pharmaceutical Drug Products

Volume: 11 | Issue: 01 | Year 2025 | Subscription
International Journal of Analytical and Applied Chemistry
Received Date: 01/04/2025
Acceptance Date: 01/11/2025
Published On: 2025-01-14
First Page: 29
Last Page: 39

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By: Dr.Kannan Jakkan, Narasimha Naidu Mopidevi, Ramanjaneyulu Seemaladinne, and Ojash Prakashbhai Doshi

Senior Director, Quality Control & ARD, ANI Pharmaceuticals, East Windsor, NJ 08520 USA.

Abstract

Substances of pharmaceutical drug products go through thorough analyses to check the safety, efficacy as well as the quality of the final product. There are a number of shortcomings even though much has been done in the analytical methods used in recalls. Such challenges are those concerning method validation, sensitivity, specificity, reproducibility, and regulation. This article on major analytical problems in current pharmaceutical drug products outlines major limitations in the current pharmaceutical drug products while stressing the need to address these challenges for the populace’s benefit. We also deliberate on problems frequently encountered in chromatographic methods, spectroscopy, dissolution tests and microbiological methods. Also, the role of such enhanced analytical instruments as High-Resolution Mass Spectrometry (HRMS) and Nuclear Magnetic Resonance (NMR) spectroscopy in addressing analytical issues is described as well. Proposals for enhancing analytical processes, such as the utilization of superior procedures for the acquired data analysis and constant quality control, are provided. The current practices in pharmaceutical analytics are revisited, and the future prospects for research and development are discussed based on an extensive survey of the existing literature and case studies.

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Citation:

How to cite this article: Dr.Kannan Jakkan, Narasimha Naidu Mopidevi, Ramanjaneyulu Seemaladinne, and Ojash Prakashbhai Doshi, Major Analytical Problems in Current Pharmaceutical Drug Products. International Journal of Analytical and Applied Chemistry. 2025; 11(01): 29-39p.

How to cite this URL: Dr.Kannan Jakkan, Narasimha Naidu Mopidevi, Ramanjaneyulu Seemaladinne, and Ojash Prakashbhai Doshi, Major Analytical Problems in Current Pharmaceutical Drug Products. International Journal of Analytical and Applied Chemistry. 2025; 11(01): 29-39p. Available from:https://journalspub.com/publication/ijaac/article=14435

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