Afatinib Impurity 17 CAS CATO-C4X-100617

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-100617
Molecular FormulaC20H18Cl2FN5O
Molecular Weight434.29 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Afatinib Impurity 17 CAS CATO-C4X-100617 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 Afatinib Impurity 17.

Afatinib Impurity 17 (CAS CATO-C4X-100617) is a certified pharmaceutical impurity reference standard with the molecular formula C20H18Cl2FN5O and a molecular weight of 434.29 g/mol.

Afatinib Impurity 17 (C20H18Cl2FN5O) 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 aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 Afatinib Impurity 17 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 FormulaC20H18Cl2FN5O
Molecular Weight434.29 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
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)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF/Cl-containing
Nitrogen Atoms5

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