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Dolutegravir
References
FAQ's
References
- Johns, Brian Alvin; Kawasuji, Takashi; Taishi, Teruhiko; Taoda, Yoshiyuki, Bicyclic Carbamoylpyridone Derivative Having HIV Integrase Inhibiting Activity, Shionogi & Co., Ltd., Japan, EP1852434B1, July 13, 2011
- Bennetto-Hood, Chantelle; Tabolt, Glenn; Savina, Paul; Acosta, Edward P., A sensitive HPLC-MS/MS method for the determination of Dolutegravir in human plasma, Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, Volume: 945-946, Pages: 225-232, 2014
Frequently Asked Questions
What methods help in the analysis of Dolutegravir impurities?
Various analytical methods such as chromatography (HPLC, LC), spectroscopy (UV, IR), and mass spectrometry help analyze Dolutegravir impurities. These methods help detect, quantify, and characterize impurities present in the drug substance.
How are impurities controlled in the manufacturing of Dolutegravir?
Strict control measures are implemented during the manufacturing process of Dolutegravir to minimize the formation of impurities. It includes optimizing reactions, using high-quality starting materials, and implementing proper storage and handling conditions to prevent degradation.
Can Dolutegravir impurities affect the drug's safety and efficacy?
Yes, impurities in Dolutegravir can potentially impact its safety and efficacy. Depending on the nature and concentration of impurities, they may introduce toxicity, reduce drug stability, or interfere with the intended therapeutic action of Dolutegravir.
What are the temperature conditions required to store Dolutegravir impurities?
Dolutegravir 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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