Erythromycin EP Impurity L CAS 127955-44-6

Purity >93%In StockPharmacopoeial Impurity Standards
CAS No.127955-44-6
Molecular FormulaC37H65NO14
Molecular Weight747.91 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Erythromycin EP Impurity L CAS 127955-44-6 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 747.91 g/mol gives Erythromycin EP Impurity L distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Erythromycin EP Impurity L (CAS 127955-44-6), a pharmacopoeial impurity reference standard (molecular formula C37H65NO14, MW 747.91 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Erythromycin EP Impurity L (C37H65NO14) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.

As a certified reference material (CRM), Erythromycin EP Impurity L 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 FormulaC37H65NO14
Molecular Weight747.91 g/mol
Purity>93%
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)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1993
Nitrogen Atoms1

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