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Apremilast
References
FAQ's
References
- Schafer, Peter H.; Muller, George W.; Man, Hon-Wah; Ge, Chuansheng, (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione: methods of using and compositions thereof, Celgene Corporation, United States, US6962940B2, November 8, 2005
- Xiong, Kaihe; Ma, Xingling; Cao, Na; Liu, Lei; Sun, Lili; Zou, Qiaogen; Wei, Ping, Identification, characterization and HPLC quantification of impurities in apremilast, Analytical Methods, Volume: 8, Issue: 8, Pages: 1889-1897, 2016
Frequently Asked Questions
How are the Apremilast impurities regulated?
Impurities in Apremilast are regulated by various international and national guidelines, such as the International Council for Harmonization (ICH) and the United States Pharmacopeia (USP).
What is the role of analytical testing in detecting impurities in Apremilast?
Analytical testing helps detect impurities in Apremilast by providing accurate and reliable data on their presence and concentration.
How are Apremilast impurities quantified?
Apremilast impurities are quantified by comparing the peak area or impurity height to that of the active pharmaceutical ingredient (API) in a chromatogram.
What are the temperature conditions required to store Apremilast impurities?
Apremilast 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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