A detailed method development and validation study was conducted to identify and evaluate the level of genotoxic impurities present in the synthetic Piperonal produced by Catàsynth Speciality Chemicals.
Potential impurities were identified as per the Route of Synthesis of Piperonal, and those impurities identified as genotoxic were monitored at ppm level as per “ICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities on pharmaceuticals to limit potential carcinogenic risk.
We are happy to inform that Synthetic Piperonal produced by Catàsynth has been certified to be free from Genotoxic, Mutagenic and Carcinogenic impurities.