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Establishing quality standards for crystalline content limits The crystalline form of a drug significantly impacts stability, dissolution rate, and bioavailability of formulations, making it a critical factor affecting drug quality. Qualitative analysis alone of the crystalline form in active pharmaceutical ingredients or formulations is insufficient to meet quality control requirements. To accurately control drug quality, especially for crystalline forms prone to polymorphic transformations, it is essential to determine the content of effective crystalline forms through quantitative analysis methods. Developing quantitative methods, coupled with formulation research data, allows for a more scientifically sound approach to establishing quality standards for drug crystalline forms. Quality control of crystalline forms in APIs and formulations Our company is equipped with the latest PXRD accessory, enabling quantitative limits for crystalline forms in active pharmaceutical ingredients (APIs) to be as low as 0.3%, with impurity crystalline form detection limits reaching a minimum of 0.1%. Equipments includes: PXRD, Raman spectroscopy, DSC (Differential Scanning Calorimetry), TGA (Thermogravimetric Analysis), DVS (Dynamic Vapor Sorption), particle size analyzer, parallel crystallization apparatus, polarizing microscope, spray dryer, fully automated ball mill |