Erythromycin EP Impurity I（Erythralosamine） CAS 546-57-6

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.546-57-6
Molecular FormulaC29H49NO8
Molecular Weight539.70 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Erythromycin EP Impurity I（Erythralosamine） CAS 546-57-6 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Erythromycin EP Impurity I（Erythralosamine）.

Erythromycin EP Impurity I（Erythralosamine） (CAS 546-57-6) is a certified pharmaceutical impurity reference standard with the molecular formula C29H49NO8 and a molecular weight of 539.70 g/mol.

Based on its molecular formula C29H49NO8, Erythromycin EP Impurity I（Erythralosamine） contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 539.70 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

As a certified reference material (CRM), Erythromycin EP Impurity I（Erythralosamine） 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 FormulaC29H49NO8
Molecular Weight539.70 g/mol
AppearanceOff-white to pale yellow crystalline powder
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)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957
Nitrogen Atoms1

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