Keywords

• Afatinib Impurity
• 162012-67-1
• C14H7ClF4N4O2

Quick Details

• ProName: Afatinib Impurity162012-67-1
• CasNo: 162012-67-1
• Molecular Formula: C14H7ClF4N4O2
• Appearance: White to off white powder
• Application: for drug impurity for drug standards,f...
• DeliveryTime: 1-2 weeks
• PackAge: 10mg/25mg/50mg/100mg/1000mg/5000mg
• Port: Shenzhen/hongkong
• ProductionCapacity: 5000 Metric Ton/Day
• Purity: 95%+ or 98%+
• Storage: -20℃
• LimitNum: 25 Milligram
• Moisture Content: 0.1%
• Impurity: 0.1%

Superiority

Our products are mainly drug impurity reference products, drug standards, analytical chemistry, standard substances, organic chemical synthesis, chemical custom synthesis. For impurity localization, quantification, and quality control in drug development processes. Our laboratory area is more than 5000 square meters, we have more than 20 analytical instruments such as HPLC and MS/LC-MS/GC-MS, we also have TGA, IR and other testing instruments. We have the most advanced SFC preparation separation equipment. We can provide a full range of impurity reference/standard products required for drug development. Most of the impurities are synthesized through the process, there are also many items of impurities can not be obtained by synthetic means, need to be obtained through raw materials, intermediates, crude products or side reactions contained in the trace target compounds, Hubei Moke has a professional impurity preparation and separation technology team, equipped with professional SFC preparation and separation equipment. It can carry out efficient and accurate separation of impurities for complex projects, and solve the problem of impurity preparation for customers.
 

1. We integrate R&D, production and sales. A 5,000-square-meter high-standard bio-intelligent manufacturing base can ensure high quality and fast delivery of products. The professional sales team ensures that you don't need to worry about pre-sales and after-sales.

2. We focus on pharmaceutical standards, pharmaceutical intermediates, pharmaceutical impurity controls, peptide customization, our own laboratory, and undertake customized synthesis projects.

3. We offer products from gram grade to g grade, in addition, some product specifications and packaging can be customized.

4. We have been deeply engaged in the pharmaceutical field for ten years and have rich experience. At present, customers are all over the world, and have been highly recognized and trusted by customers.

5. We can provide a variety of safe ways to transport goods for you to choose.

Details

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!