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2017, BJSTR
This brief review presents the international approaches to assessment of the content of geotaxis impurities (residual solvents and various inorganic and organic impurities) in pharmaceuticals. Nowadays, it has become necessary to provide not only purity profile but also impurity profile of a particular pharmaceutical product because of national and international regulations. These aspects along with significance of the quality, efficacy and safety of pharmaceuticals, including the source of impurities, kinds of impurities, control of impurities and regulatory aspects are discussed.
Journal of Pharmaceutical Research International, 2021
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.
IJPPR, 2019
Impurities are unwanted chemical substances present in the Pharmaceutical drug products and drug substances with no therapeutic benefits or some time potential to harm patient safety if present above a certain limit. The basic need in manufacturing of safe and good quality of drug substances and drug product, control of impurities is very necessary for the pharmaceutical industry. Several regulatory agencies have formulated guidelines for the control of these impurities. The present review article describes the impurities, origin of impurities, classification of impurities, control limit of impurities, guidelines for their control, isolation of impurities and its characterization using various analytical techniques.
Impurity profiling brings tremendous efforts in the group of analytical activities, the aim of which is the detection, identification/structure elucidation and quantitative determination of organic and inorganic impurities, as well as residual solvents in bulk drugs and pharmaceutical formulations. The control of impurities is currently a critical issue to the healthcare manufacturing. Various regulatory authorities like ICH, USFDA, UK-MHRA, CDSCO are emphasizing on the requirements and the identification of impurities in Active Pharmaceutical Ingredient's (API's) and as well as finished products. International Conference on Harmonization (ICH) formulated guidelines concerning the control and limit of impurities. To isolate and characterize impurities in pharmaceuticals diverse methods are used such as, capillary electrophoresis, gas–liquid chromatography, high performance liquid chromatography, solid-phase extraction methods, Ultraviolet Spectrometry, infrared spectroscopy, supercritical fluid extraction chromatography, mass spectroscopy, Nuclear magnetic resonance (NMR) spectroscopy etc. On the beginning of hyphenated techniques, the most browbeaten techniques for impurity profiling are Liquid Chromatography (LC)-Mass Spectroscopy (MS), LCNMR, LC-NMR-MS, GC-MS and fully automated Comprehensive Orthogonal Method Evaluation Technology (COMET). That is why it has plentiful claim in the field of drug design, monitoring quality, stability and as well as safety of the product.
Instrumentation Science & Technology, 2015
International Journal in Pharmaceutical Sciences, 2023
The detection and characterization of impurities in pharmaceuticals are pivotal aspects of ensuring the safety, efficacy, and quality of drug products. This review provides a comprehensive overview of the analytical techniques employed in the identification and quantification of impurities at various stages of pharmaceutical development, manufacturing, and quality control. Chromatographic methods, including High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC), are foundational for their ability to separate complex mixtures. Mass spectrometry (MS) and Nuclear Magnetic Resonance (NMR) spectroscopy offer high sensitivity and structural insights crucial for impurity characterization. The integration of these techniques, such as in Liquid Chromatography-Mass Spectrometry (LC-MS) and Liquid Chromatography-Nuclear Magnetic Resonance (LC-NMR), provides a synergistic approach to impurity analysis. Advanced hyphenated techniques enhance specificity and accuracy, allowing for real-time monitoring and dynamic adjustments during analysis. Challenges in chiral separation, degradation product analysis, and method validation are addressed through the sophistication of these methodologies. The review underscores the significance of data analysis and validation processes, ensuring the reliability of results in compliance with stringent regulatory standards. Overall, the continuous evolution and integration of analytical techniques play a pivotal role in shaping the future of pharmaceutical research, development, and quality assurance, emphasizing the commitment to producing pharmaceuticals of the highest quality and safety standards.
Impurity profiling is the process of acquiring and evaluating data that establishes biological safety of an individual impurity; thus, revealing its need and scope in pharmaceutical research. There is no clear definition for impurity in the pharmaceutical world. Impurity profiling includes identification, structure elucidation and quantitative determination of impurities and degradation products in bulk drug materials and pharmaceutical formulations. Impurity profiling has gained importance in modern pharmaceutical analysis due to the fact that unidentified, potentially toxic impurities are hazardous to health and in order to increase the safety of drug therapy, impurities should be identified and determined by selective methods. Terms such as residual solvents, byproduct, transformation products, degradation products, interaction products and related products are frequently used to define impurities. Identification of impurities is done by variety of Chromatographic and Spectroscopic techniques, either alone or in combination with other techniques. The advent of hyphenated techniques has revolutionized impurity profiling, by not only separation but structural identification of impurities as well. The present review covers various aspects related to the analytical method development for impurity profiling of an active pharmaceutical ingredient.
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