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API crystal form identification
Crystal form consistency analysis
During the manufacturing process of generic drugs, it is necessary to compare the crystal form pattern with the original API crystal form pattern to determine whether the API is consistent. Crystal form consistency proves that the drug quality and efficacy of the home-made preparation are of the same level as the original API.
Mixed crystals/solvate identification
Because drug is polymorphic, different crystal forms of the same drug molecule mixed together is called mixed crystals; some solvents by reducing the gravitational force of drug molecules or ionic bonds, and with the main body of the drug molecules together to form crystals is solvate. Whether mixed crystals or solvates, they can have a great impact on the efficacy, modulation of the rate of action, adverse effects, solubility, etc. Therefore, effective means of identification are needed to help drug optimization.
Development and validation of API crystal form analysis methods in formulations
In drug development, crystal form analysis methods are the scale for API and formulation development and quality control. In the development of API analytical methods, it is necessary to refer to the analytical methods of related compounds or similar compounds, followed by the analytical work of impurities, and to gradually optimize the analytical methods based on the mature methods in combination with the process itself.
Crystal form stability studies in APIs and formulations
In preclinical studies of drugs, the compound crystal form is affected by other factors (e.g. temperature, light, humidity, pressure, etc.) to undergo trans-crystallization, resulting in changes in drug properties. This means that each process from the API to the finished formulation may cause a change in the drug crystal form. Therefore, the study of drug crystal form stability is very important to ensure the safety and efficacy of drugs, which can provide a scientific basis for the selection of dominant drug crystal form, drug formulation prescription, preparation process, and drug storage.