1Department of Pharmaceutical Quality Assurance, Divine College of Pharmacy, Satana, Nashik, Maharashtra, India- 423301
2Department of Pharmaceutical Chemistry, Divine College of Pharmacy, Satana, Nashik, Maharashtra, India- 423301
Purity profiling involves the meticulous gathering and analysis of information to ascertain the biological safety of specific impurities, underscoring its crucial role and extensive scope within pharmaceutical research. In the realm of pharmaceuticals, the term "impurity" lacks a precise definition. Impurity profiling encompasses the identification, structural clarification, and quantitative assessment of impurities and degradation products present in bulk medicinal materials and pharmaceutical formulations. Given that undisclosed and potentially harmful impurities pose a threat to health, their detection and quantification through meticulous methods are imperative to bolster the safety of drug therapy, rendering impurity profiling increasingly pivotal in modern pharmaceutical analysis. Impurities are commonly denoted by terms such as residual solvents, byproducts, transformation products, degradation products, interaction products, and related substances. Determining impurity identities involves employing diverse chromatographic techniques alongside compliance with CGMP (Current Good Manufacturing Practices), QC (Quality Control), QA (Quality Assurance), and water activity examinations. Furthermore, a pharmaceutical ingredient must meet the criteria for novel impurities. The process of segregating and characterizing impurities assumes great significance as it enables the accumulation and assessment of data that establishes biological safety, thus highlighting the indispensability and potential of drug impurity profiling in pharmaceutical research. To effectively segregate and quantify impurities, an array of instrumental analytical methods has been consistently employed The detection and regulatory assessment of organic impurities present a formidable challenge due to the myriad sources of such impurities, including microbiological contamination, API (Active Pharmaceutical Ingredient) breakdown products, and trace amounts of intermediates
Sanket S. Gite, Nikit S. Thakare, Aditi A. Kokande, Aniket B. Bairagi, Shubham R. Jadhav, Himmat D. Sawant, Cutting-edge Techniques for Impurity Profiling in Pharmaceutical Analysis: A brief Overview, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 11, 571-587. https://doi.org/10.5281/zenodo.10213447
10.5281/zenodo.10213447
