Dacomitinib Impurity 27 CAS CATO-C4X-208627

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-208627
Molecular FormulaC18H17ClFN5O
Molecular Weight373.81 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dacomitinib Impurity 27 CAS CATO-C4X-208627 chemical structure

Description

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.

Dacomitinib Impurity 27 (CAS CATO-C4X-208627) is a certified pharmaceutical impurity reference standard with the molecular formula C18H17ClFN5O and a molecular weight of 373.81 g/mol.

Dacomitinib Impurity 27 (C18H17ClFN5O) 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC18H17ClFN5O
Molecular Weight373.81 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
StorageStore at 2-8°C, 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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