Macitentan Impurity 25 CAS 1393813-43-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1393813-43-8
Molecular FormulaC15H19BrN4O4S
Molecular Weight431.30 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Macitentan Impurity 25 CAS 1393813-43-8 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 431.30 g/mol gives Macitentan Impurity 25 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Macitentan Impurity 25 (CAS 1393813-43-8) is a certified pharmaceutical impurity reference standard with the molecular formula C15H19BrN4O4S and a molecular weight of 431.30 g/mol.

The molecular framework of Macitentan Impurity 25 (C15H19BrN4O4S) is characterized by a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, bromine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, 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.

As a certified reference material (CRM), Macitentan Impurity 25 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC15H19BrN4O4S
Molecular Weight431.30 g/mol
Purity>95%
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1991
Halogen ContentBr-containing
Nitrogen Atoms4
Sulfur Atoms1

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