Two antibody samples were characterized using column calibration and multi-detection SEC, and the results compared to show how multi-detection SEC provides more accurate data and a more complete characterization of the protein mixtures under study.
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.