Nefazodone Impurity 1 CAS CATO-C4X-33501

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-33501
Molecular FormulaC25H32ClN5O2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Nefazodone Impurity 1 CAS CATO-C4X-33501 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 Nefazodone Impurity 1.

Nefazodone Impurity 1 (CAS CATO-C4X-33501) is a certified pharmaceutical impurity reference standard with the molecular formula C25H32ClN5O2HCl and a molecular weight of 506.47 g/mol.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Nefazodone Impurity 1 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 506.47 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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), Nefazodone Impurity 1 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 FormulaC25H32ClN5O2 HCl
Molecular Weight506.47 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)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms5

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