Regorafenib Impurity 65 CAS 1403469-80-6

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1403469-80-6
Molecular FormulaC7H6Cl2N2O
Molecular Weight205.04 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Regorafenib Impurity 65 CAS 1403469-80-6 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 Regorafenib Impurity 65.

CATO supplies Regorafenib Impurity 65 (CAS 1403469-80-6), a pharmacopoeial impurity reference standard (molecular formula C7H6Cl2N2O, MW 205.04 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to an amide group, a hydroxyl group, an ether linkage, chlorine substitution, an aromatic ring system, Regorafenib Impurity 65 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 205.04 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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), Regorafenib Impurity 65 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 FormulaC7H6Cl2N2O
Molecular Weight205.04 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility)
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1991
Halogen ContentCl-containing
Nitrogen Atoms2

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