International Research Journal of Engineering and Technology (IRJET) e-ISSN: 2395-0056 Volume: 11 Issue: 07 | July 2024
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p-ISSN: 2395-0072
Current Insights and Analytical Advances in Forced Degradation and Impurity Profiling: A Comprehensive Review Nagendra Lakidi1, Praveen B. M.1,* and Bharath K. Devendra2, 1Department of Chemistry, Srinivas University, Institute of Engineering and Technology, Srinivas Nagar, Mukka,
Mangaluru-574146, Karnataka
2Department of Chemistry, M.S. Ramaiah College of Arts, Science and Commerce, MSR Nagar, MSRIT Post,
Bengalru-560054, Karnataka -----------------------------------------------------------------------***-------------------------------------------------------------------------Abstract: Impurities, particularly those linked to the active pharmaceutical ingredient (API), can compromise a drug's quality, safety, and efficacy by inducing deterioration or interactions. The effective mitigation and control of impurities in pharmaceuticals hinge on establishing safety-based limits for these impurities. Conducting a forced degradation study is a crucial component in the evaluation of degradation impurities that complies with regulatory standards for both drug substances and products. This process is formalized as a regulatory requirement in the ICH Guideline. It is very significant to characterize the sources of impurities prior to the delving into subsequent processes like analytical techniques and acceptance criteria, This characterization ensures the formulation of regulatory requirements and management plans that can be defined and adhered to. Additionally, it scrutinizes strategies for the identification, control, and determination of impurities in drug substances. Analytical techniques such as HPLC and LC-MS/MS enable the quantification of impurities at trace levels. Ultimately, the study underscores the significance of impurity analysis using HPLC along with LCMS application for elucidating the structure of unknown stress degradation compounds. Key words: Impurity profiling, HPLC, LCMS, degradation impurities, Characterization, Analytical method development
1. Introduction to Pharmaceutical impurities: The primary objective of the pharmaceutical industry is to safeguard public health by ensuring patients have access to appropriate medicines [1] with the correct dosage and efficacy at an affordable cost. Consequently, the safety and efficacy of pharmaceuticals are pivotal considerations in drug therapy [2]. The safety of a drug product relies on the toxicological properties not only of the active drug substance but also on the impurities it contains [3, 4]. Pharmaceutical impurities are undesired substances that can be present in drug formulations and can originate from various sources during the drug development and manufacturing process [5]. Effective control and monitoring of impurities are essential to ensure the safety, efficacy, and quality of pharmaceutical products [6].
1.1 Classification of Pharmaceutical Impurities: 1.1.1. Organic Impurities: Organic impurities represent a class of unintended substances that can be present in pharmaceuticals, arising from various stages of drug development and manufacturing processes. Understanding and controlling these impurities are crucial for ensuring the safety, efficacy, and overall quality of pharmaceutical products. Types of Organic Impurities: Organic impurities encompass diverse categories, including starting materials, intermediates, degradation products, and residual reagents or catalysts. Starting materials and intermediates can persist through synthesis, while degradation products may form during manufacturing or storage, potentially compromising the stability of the active pharmaceutical ingredient (API) [7]. Residual reagents and catalysts from the synthesis process pose additional challenges, as they may have adverse toxicological effects.
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