Abemaciclib Impurity 66 CAS CATO-C4X-293766

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-293766
Molecular FormulaC27H32F2N8O
Molecular Weight522.59 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Abemaciclib Impurity 66 CAS CATO-C4X-293766 chemical structure

Description

As a process- or degradation-related impurity, Abemaciclib Impurity 66 (CAS CATO-C4X-293766, C27H32F2N8O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Abemaciclib Impurity 66 (C27H32F2N8O) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. Halogen substitution raises its density and boiling point; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

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 FormulaC27H32F2N8O
Molecular Weight522.59 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)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms8

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