Siponimod impurity 27 CAS 800379-63-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.800379-63-9
Molecular FormulaC25H30F3NO2
Molecular Weight433.51 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Siponimod impurity 27 CAS 800379-63-9 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 Siponimod impurity 27.

CATO supplies Siponimod impurity 27 (CAS 800379-63-9), a pharmacopoeial impurity reference standard (molecular formula C25H30F3NO2, MW 433.51 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Siponimod impurity 27 (C25H30F3NO2) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 Siponimod impurity 27 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 FormulaC25H30F3NO2
Molecular Weight433.51 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1986
Halogen ContentF-containing
Nitrogen Atoms1

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