Darolutamide Impurity 27 CAS 1297538-27-2

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1297538-27-2
Molecular FormulaC19H17ClN6O2
Molecular Weight396.83 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Darolutamide Impurity 27 CAS 1297538-27-2 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 396.83 g/mol gives Darolutamide Impurity 27 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Darolutamide Impurity 27 (CAS 1297538-27-2) is a certified pharmaceutical impurity reference standard with the molecular formula C19H17ClN6O2 and a molecular weight of 396.83 g/mol.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Darolutamide Impurity 27 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 396.83 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.

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 FormulaC19H17ClN6O2
Molecular Weight396.83 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
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)14.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1990
Halogen ContentCl-containing
Nitrogen Atoms6

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