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Gefitinib

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Gefitinib-DCTI-C-308-Daicel
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Gefitinib Impurity 9

  • CAT Number DCTI-C-308
  • CAS Number 1608115-59-8
  • Molecular Formula C22H23ClFN4O4
  • Molecular Weight 447.89
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Gefitinib-DCTI-C-358-Daicel
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Gefitinib impurity VII

  • CAT Number DCTI-C-358
  • CAS Number 179688-53-0
  • Molecular Formula C11H10N2O4
  • Molecular Weight 234.21
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Gefitinib Morpholine N-oxide

  • CAT Number DCTI-C-356
  • CAS Number 847949-51-3
  • Molecular Formula C22H24ClFN4O4
  • Molecular Weight 462.91
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Gefitinib-DCTI-C-359-Daicel
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O-Desmethyl Gefitinib

  • CAT Number DCTI-C-359
  • CAS Number 847949-49-9
  • Molecular Formula C21H22ClFN4O3
  • Molecular Weight 432.88
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References
FAQ's

References

  1. Gibson, Keith Hopkinson, Quinazoline Derivatives, Zeneca Limited, United Kingdom, EP823900B1, April 23, 1996 |
  2. 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
  3. 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

Impurity profiling is an essential tool in the quality control of the Gefitinib drug substance to identify, monitor, and control impurities.

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.

 

An Analytical method such as RP-HPLC helps detect impurities in Gefitinib.

Gefitinib impurities should be stored at a controlled room temperature between 2-8 ⁰C or as indicated on the Certificate of Analysis (CoA).

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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