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Why is the Study of Crystals Important in Meeting Registration Regulations?

• Regulatory agencies require the thorough screening of drug polymorphisms and require pharmaceutical companies to make a validated choice of one of the forms or a prescribed mixture of forms. The U.S. FDA and the NMPA have set forth clear requirements on this in the drug declaration, requiring research on drug polymorphism and providing corresponding data.

• The development of any new drug requires a comprehensive and systematic polymorphism screening to find as many crystal forms as possible and then use various solid-state methods to conduct in-depth research and evaluation of these crystalline forms, so as to find the most suitable crystalline forms for development.

• Once the best crystal form is selected, the next step is to develop a chemical process that can consistently produces the crystal form; the final step is to optimize and control the crystallization process according to the formulation requirements for the solid state properties of the API, to determine the best process parameters for the production of these solid state properties, to ensure that the crystalline form produced has the desired physical properties, such as crystal appearance, particle size distribution, specific surface area, etc.

• This method to quality assurance through experimental design can only be realized with a very comprehensive and deep understanding of the drug crystal form.