LCGC North America
The FDA recently updated its 1987 guidelines for submitting samples and analytical data for method validation — a document that affects all analytical chemists working in the pharmacrutical industry. This article highlights the agency's recommendations of how to report and validate analytical data in all new drug applications.
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.