Simvastatin EP Impurity A(Sodium Salt) CAS 101314-97-0

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.101314-97-0
Molecular FormulaC25H39O6
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Simvastatin EP Impurity A(Sodium Salt) CAS 101314-97-0 chemical structure

Description

The occurrence of Simvastatin EP Impurity A(Sodium Salt) 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 A(Sodium Salt) (CAS 101314-97-0), a pharmacopoeial impurity reference standard (molecular formula C25H39O6Na, MW 458.57 g/mol) used for the identification and quantification of trace impurities in APIs.

Simvastatin EP Impurity A(Sodium Salt) (C25H39O6Na) 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 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.

CATO manufactures Simvastatin EP Impurity A(Sodium Salt) under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC25H39O6 Na
Molecular Weight458.57 g/mol
AppearanceOff-white to pale 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)6.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1985

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