Macitentan - NDSRI's
References
FAQ's
References
- Bolli, Martin; Boss, Christoph; Fischli, Walter; Clozel, Martine; Weller, Thomas, Novel Sulfamides and Their Use As Endothelin Receptor Antagonists, Actelion Pharmaceuticals Ltd., Switzerland, EP1345920B1, April 12, 2006
- Yu, Lixiu ; Zhou, Ying; He, Xiaomeng; Li, Huqun; Chen, Hui; Li, Weiyong, Simultaneous determination of macitentan and its active metabolite in human plasma by liquid chromatography-tandem mass spectrometry, Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, Volume: 1002, Pages: 358-363, 2015
Frequently Asked Questions
Are there specific regulatory requirements for reporting and documenting Macitentan impurities?
Regulatory authorities require manufacturers to report and document the presence of impurities in Macitentan formulations, including their identification, quantification, and compliance with specified limits.
Can Macitentan impurities affect the medicine's color, odor, or taste?
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.
Which solvent helps in analyzing Macitentan impurities?
Acetonitrile is the solvent used when analyzing many impurities in Macitentan.
What is the recommended storage temperature for Macitentan impurities?
Macitentan impurities should be stored, at a controlled room temperature, usually between 2-8 °C.
Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.