Authors: Dr. Meera S. Iyer, Mr. Ankit R. Deshmukh
Abstract: Impurity profiling and forced degradation studies are essential components of modern pharmaceutical development. These studies identify potential impurities, degradation products, and stability-indicating characteristics of active pharmaceutical ingredients (APIs). Impurities may arise during synthesis, storage, or formulation and can impact drug safety and efficacy. Forced degradation involves subjecting APIs to stress conditions such as heat, light, pH, and oxidative environments to elucidate degradation pathways. Advanced analytical methods including HPLC, LC-MS, GC-MS, and NMR are utilized for comprehensive profiling. This paper reviews methodologies, regulatory requirements, and practical considerations for impurity profiling and forced degradation studies. Tables summarize stress conditions, analytical methods, and key validation parameters. Emphasis is placed on establishing robust, reproducible, and stability-indicating methods for regulatory compliance.
Keywords: Impurity Profiling, Forced Degradation, Stability-Indicating Method, HPLC, LC-MS, API Stability, Degradation Pathways
Full Issue
| View or download the full issue | PDF 122-127 |