Advances in Impurity Profiling of Pharmaceutical Formulations

Impurity profiling has become a critical component of pharmaceutical development, quality control, and regulatory compliance. During drug manufacturing, impurities—introduced through synthesis processes, excipients, residual solvents, or degradation products—pose significant challenges to the safety, efficacy, and stability of pharmaceuticals. Impurity profiling, a systematic approach to identifying, characterizing, and quantifying these impurities, is essential for ensuring that pharmaceutical products meet stringent safety and quality standards.