Sodium Fusidate EP Impurity L CAS 74048-41-2

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.74048-41-2
Molecular FormulaC31H46O5
Molecular Weight498.69 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sodium Fusidate EP Impurity L CAS 74048-41-2 chemical structure

Description

Sodium Fusidate EP Impurity L (CAS 74048-41-2) is a certified pharmaceutical impurity reference standard with the molecular formula C31H46O5 and a molecular weight of 498.69 g/mol.

The molecular framework of Sodium Fusidate EP Impurity L (C31H46O5) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional 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.

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 FormulaC31H46O5
Molecular Weight498.69 g/mol
AppearancePale yellow to yellow crystalline powder
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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1978

Related Sodium Standards

Recommended Standards

Why CATO?