In the pharmaceutical industry, the purity of Active Pharmaceutical Ingredients (APIs) is crucial for ensuring safety, efficacy, and regulatory compliance. The presence of impurities can impact the quality of the final product, making their identification, characterization, synthesis, and isolation vital steps in the drug development process. In this blog, we’ll explore these essential aspects and their importance in pharmaceutical development.
Key words: Active Pharmaceutical Ingredients (APIs), Drug Master File (DMF), API Impurities.