Description

2-Keto Crizotinib is a key synthetic intermediate and active pharmaceutical ingredient (API) metabolite derived from the tyrosine kinase inhibitor crizotinib. It serves as a critical reference standard and research compound for pharmacokinetic, metabolic stability, and bioanalytical method development studies. This high-purity chemical is essential for pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control units engaged in oncology drug development and regulatory compliance testing. The compound is widely utilized in the global biopharmaceutical supply chain under the identifier 2-Keto Crizotinib CAS NO 1415558-82-5.

Application

• Reference standard for HPLC and LC-MS/MS quantification of crizotinib metabolites in human plasma and tissue samples
• Synthetic building block in the preparation of novel ALK/ROS1/MET inhibitor analogues for structure-activity relationship (SAR) studies
• Calibration material for bioequivalence and clinical trial bioanalysis under FDA and EMA guidelines
• Positive control in CYP450 enzyme phenotyping assays to evaluate metabolic pathways of crizotinib
• Stability-indicating impurity standard for forced degradation studies (oxidative, photolytic, hydrolytic)
• Raw material in the synthesis of labeled isotopic derivatives (e.g., 13C- or 15N-labeled 2-Keto Crizotinib) for tracer studies
• Quality assurance tool for GMP-compliant API manufacturing process validation
• Research reagent in preclinical toxicology and ADME (Absorption, Distribution, Metabolism, Excretion) profiling

Basic Information

Product Name	2-Keto Crizotinib
CAS No.	1415558-82-5
Molecular Formula	C21H18Cl2N6O
Molecular Weight	457.32 g/mol
Synonyms	2-Oxo-crizotinib; 2-Keto-crizotinib; Crizotinib ketone metabolite; (R)-3-[1-(2,6-Dichloro-3-fluorophenyl)ethoxy]-5-[1-(piperidin-4-yl)-1H-pyrazol-4-yl]isothiazole 2-oxide; N-(2,6-Dichloro-3-fluorophenyl)-N'-[5-(4-piperidyl)-1H-pyrazol-3-yl]urea 2-oxide; Crizotinib 2-keto derivative; 2-Keto-crizotinib (USAN); 1415558-82-5 (CAS)
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. All batches are tested per ICH Q5, Q7, and Q2(R2) guidelines and conform to pharmaceutical-grade purity requirements (≥99.5% by HPLC). Testing includes identification (IR, 1H-NMR), assay, residual solvents (GC), heavy metals (ICP-MS), and microbiological limits where applicable. Full traceability and batch-specific documentation support FDA, EMA, PMDA, and NMPA regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8°C under inert atmosphere (nitrogen or argon) to prevent oxidation. Keep away from moisture and direct sunlight. Handle in a cool, dry, well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥99.5%
Related Substances (HPLC)	Single impurity ≤0.1%; Total impurities ≤0.5%
Residual Solvents (GC)	Meets ICH Q3C limits
Water (Karl Fischer)	≤0.5%
Heavy Metals	≤10 ppm
Optical Rotation ([α]D20)	–25° to –35° (c = 1, in methanol)

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.