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Domperidone
References
FAQ's
References
- Vandenberk, Jan; Kennis, Ludo E. J.; Van der Aa, Marcel J. M. C.; Van Heertum, Albert A. M. Th., 1-(Benzazolylalkyl)Piperidine Derivatives, Janssen Pharmaceutica N. V., Belgium, GB1542514A, March 21, 1979 (https://portal.unifiedpatents.com/patents/patent/GB-1542514-A)
- Smit, M. J.; Sutherland, F. C. W.; Hundt, H. K. L.; Swart, K. J.; Hundt, A. F.; Els, J., Rapid and sensitive liquid chromatography-tandem mass spectrometry method for the quantitation of domperidone in human plasma, Journal of Chromatography A, Volume: 949, Issue: 1-2, Pages: 65-70, 2002
Frequently Asked Questions
How are Domperidone impurities regulated in the drug?
Regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have established guidelines and standards for the control of impurities in pharmaceuticals, including Domperidone. Compliance with these regulations is mandatory for drug manufacturers.
Can Domperidone impurities vary between different manufacturers?
Impurities in Domperidone can vary between different manufacturers due to variations in the synthetic processes, starting materials, and quality control procedures used by each manufacturer. However, all manufacturers are required to comply with regulatory standards for impurity control.
How often are Domperidone impurities monitored?
Impurities in Domperidone are monitored throughout the drug's lifecycle, from development to manufacturing and post-marketing surveillance. Regular monitoring ensures compliance with regulatory standards and identifies any potential changes or new impurities.
What are the temperature conditions required to store Domperidone impurities?
Domperidone impurities are stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA).
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