Macitentan Impurity 8 CAS 38353-06-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.38353-06-9
Molecular FormulaC4H3BrN2O
Molecular Weight174.98 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Macitentan Impurity 8 CAS 38353-06-9 chemical structure

Description

The occurrence of Macitentan Impurity 8 is closely related to an amide group, a hydroxyl group, an ether linkage, bromine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Macitentan Impurity 8 (CAS 38353-06-9) is a certified pharmaceutical impurity reference standard with the molecular formula C4H3BrN2O and a molecular weight of 174.98 g/mol.

Macitentan Impurity 8 (C4H3BrN2O) contains an amide group, a hydroxyl group, an ether linkage, bromine substitution. Halogen substitution raises its density and boiling point; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 8 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 FormulaC4H3BrN2O
Molecular Weight174.98 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1967
Halogen ContentBr-containing
Nitrogen Atoms2

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