Salt selection, polymorphism and crystallisation
JKonsult provides guidance on the requirements to screen for and select the preferred salt (or co-crystal) version and subsequent studies to evaluate the polymorphic landscape to determine the preferred polymorphic form.
We have considerable experience in the development and scale-up of crystallisations to ensure reliable and robust manufacture of the required solid state.
This experience can also be applied to intermediates, for example if the quality risk assessment determines that the purity of an intermediate is critical to the quality attributes of the drug substance or to overcome manufacturing issues such as poor filtration and drying.