Roxatidine Impurity 44 CAS 6276-54-6

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.6276-54-6
Molecular FormulaC3H8ClN
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Roxatidine Impurity 44 CAS 6276-54-6 chemical structure

Description

The occurrence of Roxatidine Impurity 44 is closely related to chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Roxatidine Impurity 44 (CAS 6276-54-6, C3H8ClNHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Roxatidine Impurity 44 (C3H8ClNHCl) is characterized by chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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 FormulaC3H8ClN HCl
Molecular Weight130.01 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)-1.0
CAS Registry Year (est.)1958
Halogen ContentCl-containing
Nitrogen Atoms1

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