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Polymorphism refers to the phenomenon where the same compound forms different crystalline can form due to various arrangements and molecular conformations.
Different crystalline forms of APIs may exhibit different physical and chemical properties. These differences can impact the stability of APIs and formulations, the production process of formulations, solubility, and bioavailability, etc. Consequently, they may affect the safety, efficacy, and quality control of drugs.
Therefore, studying the possible influences of API polymorphism and API crystal structure is crucial and serves as a key element in ensuring drug quality. The research is of significant importance for the development of generic chemical drugs.