Dirithromycin EP Impurity B CAS 869485-36-9

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.869485-36-9
Molecular FormulaC29H56N2O9
Molecular Weight576.76 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dirithromycin EP Impurity B CAS 869485-36-9 chemical structure

Description

The occurrence of Dirithromycin EP Impurity B is closely related to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Dirithromycin EP Impurity B (CAS 869485-36-9), a pharmacopoeial impurity reference standard (molecular formula C29H56N2O9, MW 576.76 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Dirithromycin EP Impurity B (C29H56N2O9) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 3.0, corresponding to approximately 3 ring(s) or double-bond equivalent(s). With a molecular weight of 576.76 g/mol, it falls into the moderately-high-molecular-weight range. 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.

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 FormulaC29H56N2O9
Molecular Weight576.76 g/mol
AppearanceWhite to pale yellow crystalline powder
Purity>90%
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)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1987
Nitrogen Atoms2

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