Rifabutin is an antibiotic used to treat infections caused by Mycobacterium avium complex (MAC) and other bacteria. However, the drug may contain impurities such as related substances, degradation products, and residual solvents. These impurities can affect the purity, safety, and efficacy of the drug, and their levels must be controlled within acceptable limits in pharmaceutical formulations. Therefore, analytical methods are developed and validated for the identification, quantification, and control of rifabutin impurities.
