Simvastatin EP Impurity N (Mixture of Diastereomers) CAS 774611-54-0

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.774611-54-0
Molecular FormulaC26H40O5
Molecular Weight432.59 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Simvastatin EP Impurity N (Mixture of Diastereomers) CAS 774611-54-0 chemical structure

Description

The occurrence of Simvastatin EP Impurity N (Mixture of Diastereomers) 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.

Simvastatin EP Impurity N (Mixture of Diastereomers) (CAS 774611-54-0) is a certified pharmaceutical impurity reference standard with the molecular formula C26H40O5 and a molecular weight of 432.59 g/mol.

Simvastatin EP Impurity N (Mixture of Diastereomers) (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 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 N (Mixture of Diastereomers) 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 FormulaC26H40O5
Molecular Weight432.59 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity97%+
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.)1986

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