Clarithromycin EP Impurity P CAS 123967-58-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.123967-58-8
Molecular FormulaC39H71NO13
Molecular Weight761.98 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Clarithromycin EP Impurity P CAS 123967-58-8 chemical structure

Description

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.

CATO supplies Clarithromycin EP Impurity P (CAS 123967-58-8), a pharmacopoeial impurity reference standard (molecular formula C39H71NO13, MW 761.98 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 EP Impurity P is typically off-white to pale yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 761.98 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 FormulaC39H71NO13
Molecular Weight761.98 g/mol
Purity>95%
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.)1992
Nitrogen Atoms1

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