Crizotinib

Crizotinib is a potent, dual inhibitor of ALK and c‑Met that disrupts tumor growth and reduces cancer spread. As an ATP‑competitive inhibitor, Crizotinib binds to the kinase domains of ALK and c‑Met, blocking downstream signaling pathways involved in tumor cell proliferation and survival. The compound is widely used in treating non‑small cell lung cancer with ALK or ROS1 gene rearrangements. Crizotinib has become a cornerstone in targeted cancer therapy and an important tool in oncology research for precision medicine. As a high‑purity reference standard, Crizotinib is indispensable for analytical method development, impurity profiling, quality control testing, and ANDA filings for generic crizotinib manufacturers. Additionally, Crizotinib serves as a critical tool compound for studying ALK and c‑Met signaling pathways and developing next‑generation kinase inhibitors.

 

Product Parameters

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Parameter	Specification
Product Name	Crizotinib
CAS Number	877399-52-5
Molecular Formula	C₂₁H₂₂Cl₂FN₅O
Molecular Weight	450.34 g/mol
Appearance	White solid
Melting Point	197-203°C
Density	1.475
logP	5.04
Solubility	DMSO (25 mg/mL); Ethanol (25 mg/mL)
Storage Condition	−20°C

 

Bioactivity

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Crizotinib (PF-02341066) is an effective inhibitor of c-Met and ALK, with IC50 values of 11 nM and 24 nM, respectively, in cell assays. It also serves as a potent ROS1 inhibitor, exhibiting a Ki value of less than 0.025 nM. Crizotinib induces autophagy in various lung cancer cell lines by inhibiting the STAT3 pathway.

 

Application

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Crizotinib is a small-molecule tyrosine kinase inhibitor (TKI) targeting anaplastic lymphoma kinase (ALK), ROS1, and another oncogenic receptor tyrosine kinase, MET.

 

Indication

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Koztunib capsules may be used for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are ALK-positive, as determined by testing methods approved by the SFDA. The approval of this indication is primarily based on evidence of objective response rate (ORR) and progression-free survival (PFS); no evidence has yet been obtained regarding its survival benefit (OS).

 

Product Quality Assurance

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has established a comprehensive quality assurance system for Crizotinib that meets the rigorous expectations of both pharmaceutical manufacturing and impurity reference standard applications:

 

Thorough analytical characterization. Each batch undergoes multi‑technique analytical release testing: HPLC purity (≥98%), melting point verification (197‑203°C), appearance verification, water content determination, residual solvent analysis (GC), and where applicable, identity confirmation by mass spectrometry.

 

Full batch traceability with retention samples. From raw material procurement through synthesis, purification, and final packaging, every step is fully documented and traceable. Each batch receives a unique lot number with sufficient retention samples maintained in accordance with Cosperpharm quality procedures.

 

Stability monitoring program. Cosperpharm conducts ongoing stability studies under recommended storage conditions. Stability summaries are available to support customer regulatory submissions.

 

Documentation ready for regulatory submission. Every shipment includes a Certificate of Analysis (COA) with batch‑specific purity and characterization data, a Material Safety Data Sheet (SDS), and customs documentation for international delivery. DMF‑ready documentation packages and custom quality agreements are available upon request.

 

Customer‑initiated quality audits. Qualified customers are welcome to audit Cosperpharm‘s manufacturing, quality control, and documentation facilities. ISO compliance documentation is available upon request.

 

 Contact Us

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For Crizotinib that meets the highest standards of quality and regulatory compliance, trust Cosperpharm — reach out to start the conversation.