Abstract
Camphorsulfonic acid salts are commonly used in the manufacturing production of active pharmaceutical ingredients (APIs) and have the potential to form alkyl camphorsulfonates, which can be considered as potential genotoxic impurities (PGIs). Alkyl camphorsulfonates should be controlled using the Threshold of Toxicological Concern (TTC) when detected in APIs due to their genotoxicity. An in silico study utilizing the ICH M7 guideline was performed in order to classify the alkyl camphorsulfonates that can be produced from the reaction of camphorsulfonic acid salts with methanol, ethanol, and isopropyl alcohol, which are commonly used solvents in API manufacturing processes. Two sensitive, reproducible, and accurate analytical methods using GC-FID and GC-MS were developed using the analytical Quality By Design (QbD) approaches for the quantitation of three alkyl camphorsulfonates in APIs satisfying the control limit of PGIs according to the TTC. The detection limits of the GC-FID method were found to be between 1.5 to 1.9 ppm, and the detection limits of the GC-MS method were found to be between 0.055 to 0.102 ppm. The method was validated in terms of accuracy, linearity, precision, detection limit, quantitation limit, specificity and robustness.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.