N-Nitroso Erythromycin EP Impurity B CAS CATO-C4X-100151

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-100151
Molecular FormulaC36H64N2O14
Molecular Weight748.90 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

N-Nitroso Erythromycin EP Impurity B CAS CATO-C4X-100151 chemical structure

Description

The molecular framework of N-Nitroso Erythromycin EP Impurity B (C36H64N2O14) 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).

N-Nitroso Erythromycin EP Impurity B (CAS CATO-C4X-100151) is a certified pharmaceutical impurity reference standard with the molecular formula C36H64N2O14 and a molecular weight of 748.90 g/mol.

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 manufactures N-Nitroso Erythromycin EP Impurity B under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC36H64N2O14
Molecular Weight748.90 g/mol
Purity>95%
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)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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