The presence of impurities, also called related substances, in an active pharmaceutical ingredient (API) can have a significant impact on the quality and safety of the drug products. Therefore, it is necessary to study the impurity profile of any API and control the impurity during the manufacturing of a drug product. As per the International Conference of Harmonization (ICH) guidelines, any impurity that forms at a level of ≥0.10% with respect to an API should be identified, ...
