FDA Nitrosamine Categorization: Small-Molecule Nitrosamine and NDSRIs
The issue of nitrosamine impurities has become one of the most significant regulatory concerns in the pharmaceutical industry since 2018.
Green Chemistry Approaches in API Impurity Synthesis
Green chemistry is no longer optional in pharmaceutical research. It is essential because the regulatory agencies expect safer processes for chemical development. Also, the companies demand cost efficiency and cleaner reactions.