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Regulatory authorities require manufacturers to report and document the presence of impurities in Macitentan formulations, including their identification, quantification, and compliance with specified limits.
Some impurities in Macitentan can contribute to changes in color, odor, or taste. Strict control measures are in place to ensure the product's organoleptic properties remain within acceptable limits.
Acetonitrile is the solvent used when analyzing many impurities in Macitentan.
Macitentan impurities should be stored, at a controlled room temperature, usually between 2-8 °C.
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