Roxatidine Impurity 61 CAS 83948-53-2

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.83948-53-2
Molecular FormulaC8H16BrNO2
Molecular Weight238.12 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Roxatidine Impurity 61 CAS 83948-53-2 chemical structure

Description

The molecular framework of Roxatidine Impurity 61 (C8H16BrNO2) is characterized by an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, bromine 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.

As a process- or degradation-related impurity, Roxatidine Impurity 61 (CAS 83948-53-2, C8H16BrNO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

As a certified reference material (CRM), Roxatidine Impurity 61 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 FormulaC8H16BrNO2
Molecular Weight238.12 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityLight-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)1.0
CAS Registry Year (est.)1980
Halogen ContentBr-containing
Nitrogen Atoms1

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