Simvastatin EP Impurity E CAS 75330-75-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.75330-75-5
Molecular FormulaC24H36O5
Molecular Weight404.54 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Simvastatin EP Impurity E CAS 75330-75-5 chemical structure

Description

The occurrence of Simvastatin EP Impurity E is closely related to a flavonoid core, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Simvastatin EP Impurity E (CAS 75330-75-5), a pharmacopoeial impurity reference standard (molecular formula C24H36O5, MW 404.54 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Simvastatin EP Impurity E (C24H36O5) is characterized by a flavonoid core, a hydroxyl group, an ether linkage. 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 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).

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), Simvastatin 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 FormulaC24H36O5
Molecular Weight404.54 g/mol
AppearanceOff-white to pale 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)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1978

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