Simvastatin EP Impurity J CAS 864357-88-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.864357-88-0
Molecular FormulaC26H40O5
Molecular Weight432.59 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Simvastatin EP Impurity J CAS 864357-88-0 chemical structure

Description

The occurrence of Simvastatin EP Impurity J is closely related to a steroid 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 J (CAS 864357-88-0), a pharmacopoeial impurity reference standard (molecular formula C26H40O5, MW 432.59 g/mol) used for the identification and quantification of trace impurities in APIs.

Simvastatin EP Impurity J (C26H40O5) contains a steroid core, a hydroxyl group, an ether linkage. 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), Simvastatin EP Impurity J 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 FormulaC26H40O5
Molecular Weight432.59 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.)1987

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