Our work and case studies
Challenge: Process chemistry route to API required hydrogenation, then salt formation. The hydrogenation product was chemically unstable until the salt was formed. On a large scale, this was adequately controlled.
In radiochemical trials, the larger dilution and higher catalyst loading required for the very small-scale synthesis led to increased degradation of the unstable intermediate and unacceptable yield.
US Biopharmaceutical Company
A flow hydrogenation reactor was used; as the chemically unstable product was formed it was fed directly into the salt formation vessel. This greatly reduced degradation.
Successful [14C]synthesis was carried out to support both non-clinical and clinical trials.