Impurity and carry-over impurity control is taken as one of the most critical quality attributes to the quality of drugs.
Baolong can provide services on the customer synthesis of impurities with respect to:
- Design synthetic route for the reference impurities
- Prepare the reference impurity in milligram to gram scale to facilitate the analytical method development and release of drug substance.
- Provide CoA of the reference impurities, with the testing data included for HPLC, 1H-NMR, 13C-NMR, MS, to meet the need of regulatory filing.
- Share the structure elucidation documents, upon the customer request.
Customised Consulting