Crystallization Process Development

The process of crystallization is widely employed in various industries due to its effectiveness as both a separation and purification technique. This method allows for the swift production of a pure crystalline product in a single operation. 

In the development of active pharmaceutical ingredients (APIs), the objective extends beyond obtaining the desired polymorphic form to encompass the precise attributes of crystal size, shape, density, yield, and purity. It is noteworthy that powders of the same polymorphic form may exhibit varied behaviors, and even minor adjustments in the process can significantly impact product quality and economic considerations. 

A comprehensive understanding of the fundamental principles of crystallization and the nuanced effects of process parameters (e.g., agitation, temperature cycling, anti-solvent addition rate, seeding protocol, drying, milling, and storage conditions) on the investigational API is essential. A well-conceived crystallization process should embody qualities of robustness, reproducibility, and scalability. 

At Seven Star, our resources and expertise are dedicated to the development of the optimal crystallization process for your API.