On the basis of in-depth research on the properties of the crystal form itself and the transformation relationship between crystal forms, Crystal Pharmatech's crystallization process development technology realizes the selection and control of the crystallization system, crystallization conditions and post-processing conditions, so as to obtain the target crystal form at the same time taking into account the API particle properties, yield and cost, etc. In the process optimization stage, Crystal Pharmatech introduced the concept of QbD (Quality by Design), analyzed the key process parameters, determined the acceptable design space, the optimal range and risk control strategy.
For metastable crystal forms, because they tend to be transformed into more thermodynamically more stable crystal forms, and the transformation relationship with other crystal forms in the crystallization system is more complicated, the development of crystallization processes is more difficult than that of thermodynamically stable crystal forms. With in-depth theoretical understanding, detailed solid-state research, and strict process control, Crystal Pharmatech has established a comprehensive process development platform for crystallization of metastable polymorphs.
