Roxithromycin impurity 31 CAS CATO-C4X-130331

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-130331
Molecular FormulaC45H39N2O17
Molecular Weight879.79 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Roxithromycin impurity 31 CAS CATO-C4X-130331 chemical structure

Description

Roxithromycin impurity 31 (CAS CATO-C4X-130331) is a certified pharmaceutical impurity reference standard with the molecular formula C45H39N2O17 and a molecular weight of 879.79 g/mol.

Roxithromycin impurity 31 (C45H39N2O17) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

As a certified reference material (CRM), Roxithromycin impurity 31 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 FormulaC45H39N2O17
Molecular Weight879.79 g/mol
Purity97%+
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)27.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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