Impurity Profiling and Forced Degradation

Impurity Profiling and Forced Degradation contains 3 topic pages in Pharmaceutical Quality Assurance.

Impurity profiling is the systematic process of detecting, quantifying, identifying, and characterising the impurities present within a drug substance or drug product, and constitutes a central pillar of pharmaceutical quality assurance because the safety of a medicinal product depends not only upon the efficacy of the active ingredient but equally upon the absence of impurities at concentrations capable of producing toxicity. This chapter examines the classification of pharmaceutical impurities, the regulatory thresholds governing their reporting, identification, and qualification, and the analytical strategies employed to characterise impurities of particular toxicological concern.