LCGC North America
This column explores and highlights recently published guidelines for bioanalytical method validation.
Understanding FDA Recommendations for N-Nitrosamine Impurity Levels
April 17th 2025We spoke with Josh Hoerner, general manager of Purisys, which specializes in a small volume custom synthesis and specialized controlled substance manufacturing, to gain his perspective on FDA’s recommendations for acceptable intake limits for N-nitrosamine impurities.