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Osimertinib Impurity N

  • CAT Number DCTI-C-156
  • CAS Number 1932710-29-6
  • Molecular Formula C31H35N7O3
  • Molecular Weight 553.67

Osimertinib Impurity-I

  • CAT Number DCTI-C-629
  • CAS Number 1801616-92-1
  • Molecular Formula C22H24N6O
  • Molecular Weight 388.48

Osimertinib Impurity-J

  • CAT Number DCTI-C-630
  • CAS Number 1820891-36-8
  • Molecular Formula C22H22N6O3
  • Molecular Weight 418.46

Osimertinib N desmethyl impurity

  • CAS NUMBER 2309762-40-9
  • MOLECULAR FORMULA C27H32ClN7O2 (HCl salt); C27H31N7O2 (Free Base)
  • MOLECULAR WEIGHT 522.05 (HCl salt); 485.59 (Free Base)

Osimertinib N-Oxide

  • CAT Number DCTI-C-154
  • CAS Number 1975982-94-5
  • Molecular Formula C28H33N7O3
  • Molecular Weight 515.62

Osimertinib N,N’-Dioxide

  • CAT Number DCTI-C-155
  • CAS Number 2411395-23-6
  • Molecular Formula C28H33N7O4
  • Molecular Weight 531.62


  • CAT Number DCTI-A-208
  • CAS Number 1638281-44-3
  • Molecular Formula C28H27D6N7O2
  • Molecular Weight 505.66

General Information

Osimertinib Impurities and Osimertinib  

Daicel Pharma synthesizes high-quality Osimertinib impurities such as Osimertinib Impurity N, Osimertinib N desmethyl impurity, Osimertinib N-Oxide, Osimertinib N, N’-Dioxide, Osimertinib Impurity-J, and Osimertinib Impurity-I, crucial in the analysis of the quality, stability, and biological safety of the active pharmaceutical ingredient, Osimertinib. Moreover, Daicel Pharma offers custom synthesis of Osimertinib impurities and delivers them globally.

 Osimertinib [CAS: 1421373-65-0] is a small molecule, tyrosine kinase receptor inhibitor, and antineoplastic agent. It treats certain forms of advanced non-small cell lung cancer (NSCLC).

Osimertinib: Use and Commercial Availability  

Osimertinib is an oral medication sold under the brand name Tagrisso. It treats adults with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC that has progressed on or after EGFR TKI therapy. Further, Tagrisso is the first treatment for patients having ‘activating mutations’ whose cancer has advanced or spread.

Osimertinib Structure and Mechanism of Action Osimertinib Structure and Mechanism of Action

The chemical name of Osimertinib is N-[2-[[2-(Dimethylamino)ethyl]methylamino]-4-methoxy-5-[[4-(1-methyl-1H-indol-3-yl)-2-pyrimidinyl]amino]phenyl]-2-propenamide. Its formula for Osimertinib is C28H33N7O2, and its molecular weight is approximately 499.6 g/mol.

 Osimertinib is an EGFR kinase inhibitor, and it irreversibly binds to certain mutant forms of EGFR (T790M, L858R, exon 19 deletion). It binds at approximately 9-fold lower concentrations than wild-type EGFR.

Osimertinib Impurities and Synthesis 

Osimertinib may contain related substances and process impurities that impact its final purity, yield, and quality. It is crucial to regulate impurity levels in Osimertinib to maintain the drug’s safety and effectiveness.

Daicel offers a Certificate of Analysis (CoA) from a cGMP-compliant analytical facility for Osimertinib impurity standards, including Osimertinib Impurity N, Osimertinib N-desmethyl impurity, Osimertinib N-Oxide, Osimertinib N, N’-Dioxide, Osimertinib Impurity-J, and Osimertinib Impurity-I. The CoA includes complete characterization data, such as 1H NMR, 13C NMR, IR, MASS1, and HPLC purity2. We also provide 13C-DEPT and CHN on request. We also give a complete characterization report on delivery.

Daicel has the technology and expertise to prepare any unknown Osimertinib impurity or degradation product. Daicel also provides labeled compounds to quantify the efficacy of generic Osimertinib. Daicel offers Osimertinib-D6, a deuterium-labeled standard of Osimertinib for bioanalytical research and BA/BE studies.



Frequently Asked Questions

The most common impurities in Osimertinib are N-desmethyl Osimertinib, Osimertinib N-oxide, Osimertinib oxide, and Osimertinib desmethoxy.

Impurities in Osimertinib can potentially affect its stability, leading to drug degradation over time. It could affect the safety, efficacy, and shelf life of the drug.

Impurities in Osimertinib detection are through analytical methods such as high-performance liquid chromatography (HPLC), liquid chromatography mass spectrometry (LC-MS), etc.

Osimertinib impurities removal is by purification steps, such as crystallization or chromatography.

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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