Flucloxacillin EP Impurity E CAS CATO-C4X-16475

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-16475
Molecular FormulaC27H27ClFN5O7S2
Molecular Weight652.11 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Flucloxacillin EP Impurity E CAS CATO-C4X-16475 chemical structure

Description

The occurrence of Flucloxacillin EP Impurity E is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Flucloxacillin EP Impurity E (CAS CATO-C4X-16475) is a certified pharmaceutical impurity reference standard with the molecular formula C27H27ClFN5O7S2 and a molecular weight of 652.11 g/mol.

Flucloxacillin EP Impurity E (C27H27ClFN5O7S2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, 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).

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.

As a certified reference material (CRM), Flucloxacillin EP Impurity E 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 FormulaC27H27ClFN5O7S2
Molecular Weight652.11 g/mol
Purity>95%
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)16.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF/Cl-containing
Nitrogen Atoms5
Sulfur Atoms2

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