Clarithromycin impurity 14 CAS 138109-92-9

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.138109-92-9
Molecular FormulaC38H69NO13
Molecular Weight747.95 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Clarithromycin impurity 14 CAS 138109-92-9 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 Clarithromycin impurity 14 (CAS 138109-92-9), a pharmacopoeial impurity reference standard (molecular formula C38H69NO13, MW 747.95 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Clarithromycin impurity 14 is typically off-white to pale yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 747.95 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 FormulaC38H69NO13
Molecular Weight747.95 g/mol
Purity>90%
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1996
Nitrogen Atoms1

Related Clarithromycin Standards

Recommended Standards

Why CATO?