Crystallization Process Development

Crystallization is one of the most widely used techniques in industry.  It can be attributed to the fact that crystallization acts as both a separation and purification technique.  In a single step, crystal product of the desired purity can be achieved and then isolated.  

When it comes to crystallization process development of active pharmaceutical ingredients (APIs), the job is not only to produce the desired (selected) polymorphic form but also produce the API solids with desired product attributes such as crystal size, shape, density, yield, and purity.  Note that not all powders of the same polymorphic form of an API behave in the same way.  Small changes in the process can result undesirable product quality and economic impact to the drug development program.  Hence it is very important to understand the fundamentals of crystallization in general and effect of process parameters (for example agitation, temperature cycling, anti-solvent addition rate, seeding protocol, drying, milling, and storage conditions) specifically to the API that is under investigation (or investigational API).  An ideal crystallization process must be robust, reproducible and scalable. 

At Seven Star we have right tools and expertise to discover the ideal crystallization process of your API.