Analytical Methods and Their Significance in Pharmaceutical Process Impurities: A Review

Potential genotoxic substances in medicines are of rising concern to pharmaceutical and regulatory authorities at detectable levels due to their potential to induce human carcinogenesis. Molecule functional groups may contribute to the genotoxicity of small molecules by converting starting materials and synthetic intermediates into reactive components. It is challenging for the pharmaceutical research and development analytical community to identify these genotoxic chemicals at trace levels without using susceptible and selective analytical methods. The literature currently needs more experimental advice for analyzing some significant contaminants. Analytical methods play a vital role in the pharmaceutical industry for monitoring and controlling impurities in drug products. These methods provide critical information on the final product's quality, purity, and efficacy by identifying unwanted substances such as degradation products, residual solvents, and process contaminants. The significance of analytical methods in pharmaceutical process impurities includes ensuring quality control, regulatory compliance, process optimization, troubleshooting, and batch release. These methods help to ensure that the final product meets the required specifications, complies with regulatory requirements, and provides the safe and effective patient treatment. The study analyses the structural alarms of commonly encountered likely genotoxic contaminants and draught regulations of various regulatory authorities to restrict the number of impurities in medicinal substances and to identify their toxicity. © 2024 Wiley-VCH GmbH.