Mirabegron EP Impurity B CAS 391901-45-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.391901-45-4
Molecular FormulaC16H20N2O
Molecular Weight256.34 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Mirabegron EP Impurity B CAS 391901-45-4 chemical structure

Description

As a certified reference material (CRM), Mirabegron EP Impurity B 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.

As a process- or degradation-related impurity, Mirabegron EP Impurity B (CAS 391901-45-4, C16H20N2O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Mirabegron EP Impurity B (C16H20N2O) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

Physical & Chemical Properties

Molecular FormulaC16H20N2O
Molecular Weight256.34 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2025
Nitrogen Atoms2

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