Sodium Fusidate EP Impurity D CAS CATO-C4X-11974

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-11974
Molecular FormulaC31H48O7
Molecular Weight532.71 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sodium Fusidate EP Impurity D CAS CATO-C4X-11974 chemical structure

Description

The occurrence of Sodium Fusidate EP Impurity D is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Sodium Fusidate EP Impurity D (CAS CATO-C4X-11974, C31H48O7) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Sodium Fusidate EP Impurity D (C31H48O7) contains a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system. The carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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), Sodium Fusidate EP Impurity D 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 FormulaC31H48O7
Molecular Weight532.71 g/mol
AppearancePale yellow to 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)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present

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