Tips & Tricks: GPC/SEC Result Uncertainty - How Reliable Are Results?
GPC/SEC results and their validity are crucial in many applications, for example, as part of a QC/QA test for a product release, the registration and accreditation of polymeric products or formulations with regulatory agencies such as the FDA, REACH and many more. Obviously, the accuracy and precision of GPC/SEC results is an important issue in such a context.
GPC/SEC results and their validity are crucial in many applications, for example, as part of a QC/QA test for a product release, the registration and accreditation of polymeric products or formulations with regulatory agencies such as the FDA, REACH and many more. Obviously, the accuracy and precision of GPC/SEC results is an important issue in such a context.
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.
