Crizotinib impurity 27 CAS CATO-C4X-102527

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-102527
Molecular FormulaC21H22Cl2FN5O
Molecular Weight450.34 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Crizotinib impurity 27 CAS CATO-C4X-102527 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Crizotinib impurity 27.

As a process- or degradation-related impurity, Crizotinib impurity 27 (CAS CATO-C4X-102527, C21H22Cl2FN5O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Crizotinib impurity 27 (C21H22Cl2FN5O) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. Halogen substitution raises its density and boiling point; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

CATO manufactures Crizotinib impurity 27 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC21H22Cl2FN5O
Molecular Weight450.34 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity≥95%
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF/Cl-containing
Nitrogen Atoms5

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