Crystallization is the most common unit operation for isolation and purification of solid intermediates and active pharmaceutical ingredients (APIs). As the end point of both the chemical development process and later manufacturing, the quality of the API delivered has a direct impact upon drug product formulation development and manufacturing.
A well-designed crystallization process and sufficient knowledge of the solid-state properties of a drug substance are essential to ensure high product purity and that the desired crystal modification is delivered consistently. Since the particle size distribution of the product depends upon both the solvent/solute system used and process parameters and equipment properties, crystallization can be employed to engineer particles precisely and with the right properties that ensure the optimum performance of the drug product.
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