Difamilast Impurity 2 CAS 2103190-94-7

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.2103190-94-7
Molecular FormulaC23H24F2N2O6
Molecular Weight462.44 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Difamilast Impurity 2 CAS 2103190-94-7 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 Difamilast Impurity 2.

As a process- or degradation-related impurity, Difamilast Impurity 2 (CAS 2103190-94-7, C23H24F2N2O6) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C23H24F2N2O6, Difamilast Impurity 2 contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 462.44 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

As a certified reference material (CRM), Difamilast Impurity 2 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC23H24F2N2O6
Molecular Weight462.44 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1997
Halogen ContentF-containing
Nitrogen Atoms2

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