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Gefitinib
References
FAQ's
References
- Gibson, Keith Hopkinson, Quinazoline Derivatives, Zeneca Limited, United Kingdom, EP823900B1, April 23, 1996 |
- Jones, H. K.; Stafford, L. E.; Swaisland, H. C.; Payne, R., A sensitive assay for ZD1839 (Iressa) in human plasma by liquid-liquid extraction and high performance liquid chromatography with mass spectrometric detection: validation and use in Phase I clinical trials, Journal of Pharmaceutical and Biomedical Analysis, Volume: 29, Issue: 1-2,Pages: 221-228, 2002
- Bai, Feng; Iacono, Lisa C.; Johnston, Brad; Stewart, Clinton F., Determination of Gefitinib in Plasma by Liquid Chromatography with a C12 Column and Electrospray Tandem Mass Spectrometry Detection, Journal of Liquid Chromatography & Related Technologies, Volume: 27, Issue: 17, Pages: 2743-2758, 2004
Frequently Asked Questions
What is the role of impurity profiling in the quality control of Gefitinib?
Impurity profiling is an essential tool in the quality control of the Gefitinib drug substance to identify, monitor, and control impurities.
What are degradation impurities in Gefitinib?
Degradation impurities in Gefitinib are the impurities formed during the manufacturing process or storage of the drug product. These impurities can arise from the breakdown of Gefitinib due to various factors such as heat, light, moisture, and pH.
How can Gefitinib impurities be detected?
An Analytical method such as RP-HPLC helps detect impurities in Gefitinib.
What are the temperature conditions required to store Gefitinib impurities?
Gefitinib impurities should be stored at a controlled room temperature between 2-8 ⁰C or as indicated on the Certificate of Analysis (CoA).
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