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Postion:Product Catalog >Pharmaceutical intermediates>Bulk Drug Intermediates>Afatinib Impurity
Afatinib Impurity
  • Afatinib Impurity
  • Afatinib Impurity
  • Afatinib Impurity
  • Afatinib Impurity
  • Afatinib Impurity

Afatinib Impurity NEW

Price Get Latest Price
Package 10mg 50mg 100mg
Min. Order: 10mg
Supply Ability: 1000
Update Time: 2025-12-16

Product Details

Product Name: Afatinib Impurity CAS No.: 162012-67-1
Min. Order: 10mg Purity: 99%+ HPLC
Supply Ability: 1000 Release date: 2025/12/16

Afatinib Impurity


Article illustration

Product Information

  • Product Code:A003114

  • English Name:Afatinib Impurity 114

  • English Alias:N-(3-chloro-4-fluorophenyl)-7-fluoro-6-nitroquinazolin-4-amine

  • CAS No.:162012-67-1

  • Molecular Formula:C??H?ClF?N?O?

  • Molecular Weight:336.68

Advantages

  • High-Purity Reference Standard:Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for precise analysis of Afatinib impurities.

  • Stability Assurance:Stable for 24 months at -20℃ under light-protected, sealed storage; degradation rate <0.5% in acetonitrile solution within 3 months.

Applications

  • Quality Control Testing:Used for UPLC-MS/MS detection of Impurity 114 in Afatinib API and formulations, controlling impurity content to meet ICH Q3A standards (≤0.1%).

  • Process Optimization Research:Monitors impurity formation during Afatinib synthesis, reducing generation by >60% by adjusting nitration temperature (e.g., 0-5℃) and fluorinating agent dosage.

  • Method Validation:Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥2.0) and LOD (0.005 ng/mL).

Background Description

Afatinib, an oral tyrosine kinase inhibitor, is used in treating non-small cell lung cancer. Impurity 114 may originate from side reactions during Afatinib synthesis, such as nitration or halogenation of the quinazoline ring. The nitro and halogen groups in its structure may affect drug stability and efficacy. With stricter EMA requirements for oncology drug impurity control, studying such process impurities is key to ensuring drug quality.

Research Status

  • Detection Technology:UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 2.8 minutes, with LOD of 0.003 ng/mL for high-sensitivity analysis.

  • Formation Mechanism:Formed by condensation of 3-chloro-4-fluoroaniline with 7-fluoro-6-nitroquinazoline intermediate; optimizing reaction pH (7.0-7.5) and time (≤4h) inhibits side reactions.

  • Safety Evaluation:In vitro cytotoxicity shows IC?? of 56.7 μM against A549 cells (Afatinib IC??=0.12 μM), with low toxicity but requiring ≤0.1% limit. Accelerated stability testing is ongoing for degradation monitoring.


We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.


This product is intended for laboratory use only!

WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com


NEW IN STOCK!

The Molcoo Laboratory added drug impurity reference standards, including Baricitinib, Piperazine, Benzylpenicillin, Tranilast and multiple N-Nitroso drug impurities! Now available for immediate delivery! 








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