Riociguat Impurity N40 CAS 428854-23-3

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.428854-23-3
Molecular FormulaC23H18FN9
Molecular Weight439.45 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Riociguat Impurity N40 CAS 428854-23-3 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 Riociguat Impurity N40.

As a process- or degradation-related impurity, Riociguat Impurity N40 (CAS 428854-23-3, C23H18FN9) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Riociguat Impurity N40 (C23H18FN9) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine substitution. Halogen substitution raises its density and boiling point; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

As a certified reference material (CRM), Riociguat Impurity N40 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 FormulaC23H18FN9
Molecular Weight439.45 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)19.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2025
Halogen ContentF-containing
Nitrogen Atoms9

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