Three-Pronged Approach (Active Pharmaceutical Ingredients, Excipients, and NOx-Free Air) Successfully Suppressed the Formation of Nitroso-atomoxetine to 0.097 ppm

News of “carcinogenic nitrosamines in pharmaceutical products” circulates around the world, and regulatory agencies and pharmaceutical companies are facing challenges in reducing the presence of nitrosamines. A variety of causes affect the presence of nitrosamine and complicate the mitigation process. However, our three-pronged approach combining empirical knowledge has successfully reduced the level of nitroso-atomoxetine to 0.097 ppm.