Abstract

COMPREHENSIVE STUDY ABOUT THE APPROACHES OF BUILDING UP IMPURITY PROFILING FROM AN INDUSTRIAL VIEWPOINT

Souvik Kundu*, Debraj Paul, Rahul Patra and Jaydip Ray

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Abstract

In the field of health research impurity profiling carries a crucial job in drug safety, efficacy, and quality. Impurities may be incorporated with drug or pharmaceutical molecules in any stage of manufacturing including the time of synthesis, processing, storing, degrading due to environmental factors, or in the time of transportation of APIs. Indeed, even in trace amounts, it very well may involve issues with the dosage form. To overcome impurity problem, profiling is mandatory and includes steps like identification, isolation, characterization, quantification, and separation. Major sophisticated instruments like chromatography, spectroscopy are involved in this process. Impurity profiling helps in identifying the drug's compatibility, stability concern, microbial activity, interactions, or degradation pathways and furthermost the related harmfulness profile. Thus, it is helps in upregulation of shelf life of product. Global bodies like USFDA, EU, TGA, and EMA are involved in monitoring and responsible for introducing guidelines and SOPs to minimize and control the impurity in between acceptance ranges. Globally, for the pharmaceutical field, it is a major worry of research and continuous advancements are made in analytical methodologies for more critical and updated characterization by which accurate assessments are finished and minimize impurity as well as possible throughout the product life cycle. This comprehensive study examines the various approaches used in the industrial setting to build up impurity profiling. The study explores the analytical techniques, strategies, and considerations involved in identifying, characterizing, and quantifying impurities. It also discusses the challenges faced by industrial practitioners and the emerging trends in impurity profiling.

Keywords: APIs, USFDA, EMA, Spectroscopy, Toxicity profiling, SOPs.