Azithromycin impurity 60 CAS CATO-C4X-100360

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-100360
Molecular FormulaC37H70N2O14S
Molecular Weight799.02 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Azithromycin impurity 60 CAS CATO-C4X-100360 chemical structure

Description

As a certified reference material (CRM), Azithromycin impurity 60 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.

As a process- or degradation-related impurity, Azithromycin impurity 60 (CAS CATO-C4X-100360, C37H70N2O14S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Azithromycin impurity 60 (C37H70N2O14S) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone 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. 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.

Physical & Chemical Properties

Molecular FormulaC37H70N2O14S
Molecular Weight799.02 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)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2
Sulfur Atoms1

Related Azithromycin Standards

Recommended Standards

Why CATO?