Clemastine Impurity 7 Fumarate (R,S-isomer) CAS 61826-30-0

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.61826-30-0
Molecular FormulaC21H26ClNO
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Clemastine Impurity 7 Fumarate (R,S-isomer) CAS 61826-30-0 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 459.97 g/mol gives Clemastine Impurity 7 Fumarate (R,S-isomer) distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Clemastine Impurity 7 Fumarate (R,S-isomer) (CAS 61826-30-0), a pharmacopoeial impurity reference standard (molecular formula C21H26ClNOC4H4O4, MW 459.97 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Clemastine Impurity 7 Fumarate (R,S-isomer) (C21H26ClNOC4H4O4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 11.0, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 459.97 g/mol, it falls into the moderately-high-molecular-weight range. 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.

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 FormulaC21H26ClNO C4H4O4
Molecular Weight459.97 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1974
Halogen ContentCl-containing
Nitrogen Atoms1

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