Clemastine Impurity 22 CAS CATO-C4X-183722

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-183722
Molecular FormulaC21H26ClNO
Molecular Weight343.89 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Clemastine Impurity 22 CAS CATO-C4X-183722 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 Clemastine Impurity 22.

Clemastine Impurity 22 (CAS CATO-C4X-183722) is a certified pharmaceutical impurity reference standard with the molecular formula C21H26ClNO and a molecular weight of 343.89 g/mol.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Clemastine Impurity 22 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 343.89 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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), Clemastine Impurity 22 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 FormulaC21H26ClNO
Molecular Weight343.89 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms1

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