Fingolimod EP Impurity H CAS 162358-09-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.162358-09-0
Molecular FormulaC25H39NO5
Molecular Weight433.58 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fingolimod EP Impurity H CAS 162358-09-0 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 433.58 g/mol gives Fingolimod EP Impurity H distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Fingolimod EP Impurity H (CAS 162358-09-0, C25H39NO5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Fingolimod EP Impurity H (C25H39NO5) contains a flavonoid core, an amide group, 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 Fingolimod EP Impurity H 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 FormulaC25H39NO5
Molecular Weight433.58 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.)2003
Nitrogen Atoms1

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