Bupropion - NDSRI's
References
FAQ's
References
- Mehta, Nariman B.; Yeowell, David A., Meta Chloro Substituted-Alpha-Butylamino-Propiophenones, Wellcome Foundation Ltd., US3819706A, June 25, 1974
- Cooper, Thomas B.; Suckow, Raymond F.; Glassman, Alexander, Determination of bupropion and its major basic metabolites in plasma by liquid chromatography with dual-wavelength ultraviolet detection, Journal of Pharmaceutical Sciences, Volume: 73, Issue: 8, Pages: 1104-7, 1984
- Al-Khamis, Khalil I., Rapid determination of bupropion in human plasma by high-performance liquid chromatography, Journal of Liquid Chromatography, Volume: 12, Issue: 4, Pages: 645-55, 1989
Frequently Asked Questions
How often should impurity testing be conducted on Bupropion drug products?
Impurity testing should be conducted at regular intervals during drug development, including during the synthesis of the API, production of drug products, and stability studies. The testing frequency depends on the regulatory requirements and the risk associated with the impurities.
Can impurities in Bupropion affect drug efficacy?
Yes, impurities in Bupropion can affect the drug efficacy by reducing the potency of the API or interfering with its mechanism of action.
How do you detect the impurities in Bupropion?
The detection of impurities in Bupropion is through analytical methods such as high-performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LC-MS), etc.
What are the temperature conditions required to store Bupropion impurities?
Bupropion 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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