Darolutamide Impurity 14 CAS CATO-C4X-310614

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-310614
Molecular FormulaC19H19ClN6O2
Molecular Weight398.85 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Darolutamide Impurity 14 CAS CATO-C4X-310614 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 Darolutamide Impurity 14.

Darolutamide Impurity 14 (CAS CATO-C4X-310614) is a certified pharmaceutical impurity reference standard with the molecular formula C19H19ClN6O2 and a molecular weight of 398.85 g/mol.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Darolutamide Impurity 14 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 398.85 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.

CATO manufactures Darolutamide Impurity 14 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 FormulaC19H19ClN6O2
Molecular Weight398.85 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity≥95%
StorageStore at 2-8°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)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms6

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