Budesonide EP Impurity D (Mixture of Epimer) CAS 85234-63-5

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.85234-63-5
Molecular FormulaC25H32O6
Molecular Weight428.52 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Budesonide EP Impurity D (Mixture of Epimer) CAS 85234-63-5 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Budesonide EP Impurity D (Mixture of Epimer).

Budesonide EP Impurity D (Mixture of Epimer) (CAS 85234-63-5) is a certified pharmaceutical impurity reference standard with the molecular formula C25H32O6 and a molecular weight of 428.52 g/mol.

The molecular framework of Budesonide EP Impurity D (Mixture of Epimer) (C25H32O6) 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.

CATO manufactures Budesonide EP Impurity D (Mixture of Epimer) 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 FormulaC25H32O6
Molecular Weight428.52 g/mol
AppearancePale yellow to 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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1981

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