Sodium Fusidate EP Impurity F CAS 1415035-94-7

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1415035-94-7
Molecular FormulaC31H46O7
Molecular Weight530.69 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sodium Fusidate EP Impurity F CAS 1415035-94-7 chemical structure

Description

The occurrence of Sodium Fusidate EP Impurity F 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 F (CAS 1415035-94-7, C31H46O7) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Sodium Fusidate EP Impurity F (C31H46O7) 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 aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC31H46O7
Molecular Weight530.69 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.)1991

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