Lenalidomide
References
- Muller, George W.; Stirling, David I.; Chen, Roger S. -c, Substituted 2(2,6-Dioxopiperidin-3-Yl)Phthalimides And -1-Oxoisoindolines And Method Of Reducing TNF-Alpha Levels, Celgene Corp., United States, WO9803502A1, January 29, 1998
- Tohnya, Tanyifor M.; Hwang, Kyunghwa; Lepper, Erin R.; Fine, Howard A.; Dahut, William L.; Venitz, Juergen; Sparreboom, Alex; Figg, William D., Determination of CC-5013, an analogue of thalidomide, in human plasma by liquid chromatography-mass spectrometry, Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, Volume: 811, Issue: 2, Pages: 135-141, 2004
Frequently Asked Questions
How are Lenalidomide impurities detected and quantified?
Analytical techniques such as high-performance liquid chromatography (HPLC), liquid chromatography (LC), or mass spectrometry (MS) help detect and quantify Lenalidomide impurities.
How are Lenalidomide impurities controlled during the manufacturing process?
Stringent quality control measures are implemented during the manufacturing process of Lenalidomide to minimize impurities. It includes monitoring and optimizing reaction conditions, purification steps, and storage conditions.
Can Lenalidomide impurities affect the drug's stability and shelf life?
Yes, impurities in Lenalidomide can contribute to the degradation and reduce its stability over time, potentially impacting its shelf life and therapeutic effectiveness.
How should Lenalidomide impurities be stored in terms of temperature?
The recommendation is to store Lenalidomide impurities at a controlled room temperature, within 2-8 °C.
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