Rupatadine impurity 33 HCl CAS CATO-C4X-102733

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-102733
Molecular FormulaC7H8ClNO
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Rupatadine impurity 33 HCl CAS CATO-C4X-102733 chemical structure

Description

The occurrence of Rupatadine impurity 33 HCl is closely related to an amide group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Rupatadine impurity 33 HCl (CAS CATO-C4X-102733) is a certified pharmaceutical impurity reference standard with the molecular formula C7H8ClNOHCl and a molecular weight of 194.06 g/mol.

Structurally, Rupatadine impurity 33 HCl (C7H8ClNOHCl) contains an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 3.0, corresponding to approximately 3 ring(s) or double-bond equivalent(s). With a molecular weight of 194.06 g/mol, it falls into the medium-molecular-weight range. 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.

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 FormulaC7H8ClNO HCl
Molecular Weight194.06 g/mol
AppearanceWhite to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility)
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
Halogen ContentCl-containing
Nitrogen Atoms1

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