Azithromycin Impurity 44 CAS 2365312-76-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.2365312-76-9
Molecular FormulaC30H60N2O10
Molecular Weight608.80 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Azithromycin Impurity 44 CAS 2365312-76-9 chemical structure

Description

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.

CATO supplies Azithromycin Impurity 44 (CAS 2365312-76-9), a pharmacopoeial impurity reference standard (molecular formula C30H60N2O10, MW 608.80 g/mol) used for the identification and quantification of trace impurities in APIs.

Azithromycin Impurity 44 (C30H60N2O10) contains an amide group, a carboxylic acid 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.

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 FormulaC30H60N2O10
Molecular Weight608.80 g/mol
Purity97%+
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1999
Nitrogen Atoms2

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