Degradation Impurities are chemical substances that form when Active Pharmaceutical Ingredients (APIs) or finished pharmaceutical products degrade over time due to factors such as heat, light, moisture, oxidation, or pH changes. Their identification and characterization play a vital role in pharmaceutical development, stability studies, and quality assurance.
Understanding degradation impurities helps manufacturers evaluate the stability of drug products, establish appropriate storage conditions, determine shelf life, and ensure compliance with international regulatory guidelines such as those issued by ICH. Effective impurity profiling and analytical testing contribute to the development of safe, effective, and high-quality medicines throughout their lifecycle.
