As an orally highly selective CDK4/6 inhibitor, Abemaciclib is a core targeted drug for the treatment of HR+/HER2- breast cancer, widely used in the clinical treatment of locally advanced and metastatic breast cancer. Its synthesis chain has stringent requirements for the purity, stability and batch consistency of key intermediates, which directly determine the quality of active pharmaceutical ingredients (APIs) and the safety of preparations.
Jinan Zhonghan Chemical Technology Co., Ltd. focuses on the R&D and large-scale production of high-end pharmaceutical intermediates. Relying on mature processes, strict quality control and customized production capacity, we have launched a series of high-purity key intermediates for Abemaciclib, covering key nodes of core skeleton construction and side chain synthesis, providing pharmaceutical enterprises with stable, compliant and cost-effective raw material support
Product Positioning and Core Value
Our Abemaciclib Intermediates are positioned to meet the needs of commercial API production, with the core advantages of high purity, low impurities, stable process and scalability. They are suitable for the whole process from laboratory small-scale test to industrial mass production, helping customers shorten R&D cycles, reduce production costs, and improve pharmaceutical compliance and market competitiveness.
Core Intermediates and Key Indicators
- 4-Bromo-2,6-difluoroaniline
CAS: 67567-26-4
Purity ≥99.5%, single impurity ≤0.1%. Moisture and metal residues are strictly controlled. It is suitable for cyclization and coupling reactions with stable yield.
- N-Isopropylacetamide
CAS: 1118-69-0
As a key building block for amidination and cyclization, it features high purity and controllable impurities, supports continuous processes and improves the overall yield.
- Other Customized Intermediates: We provide one-stop services including custom development, process optimization and pilot scale-up according to customers' synthetic routes, meeting the needs of patent circumvention and differentiated synthesis.
Technical and Quality Advantages
- Mature and Stable Process: Adopting optimized synthetic routes with mild reaction conditions, few by-products and compliant three-waste treatment, suitable for continuous production.
- Stringent Quality System: Implementing the ISO9001 quality management system, establishing a full-item detection and traceability system for genotoxic impurities, heavy metals, residual solvents, etc., with strong batch consistency.
- Reliable Delivery Guarantee: Combining standardized production with flexible capacity, providing stable supply from gram-level to ton-level, supporting rapid response and long-term price locking.
- Professional Technical Support: Equipped with a professional R&D and technical service team, providing supporting services such as process parameters, post-treatment and purification schemes.
Application Scenarios
Our products are targeted at domestic and foreign API manufacturers, CDMO/CMO and innovative drug R&D institutions, used for the synthesis, process verification, registration application and commercial production of Abemaciclib API, fully meeting the compliance requirements of China NMPA, US FDA, EU CEP and other regulatory authorities.
About Zhonghan Biotech
Jinan Zhonghan Chemical Technology Co., Ltd. specializes in the R&D and preparation of high-value-added new drug intermediates and active small molecule inhibitors, focusing on therapeutic fields such as anti-tumor and cardiovascular diseases, integrating R&D, pilot test, production and sales. With modern production workshops, a professional R&D platform and a number of invention patents, the company adheres to the philosophy of innovation-driven, quality-oriented and customer-first, and continuously provides reliable raw materials and technical solutions for the global pharmaceutical industry.
Business and Technical Enquiry
For product COA, spectra, quotation and custom development solutions, please contact us:
Tel: [18562151612]
Email: [2289008634@qq.com]
Official Website: https://www.xsu.com/
Media Contact
Company Name: Jinan Zhonghan Chemical Technology Co., LTD.
Email: Send Email
Country: China
Website: www.xsu.com
