Mizolastine Impurity 8 CAS CATO-C4X-20068

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-20068
Molecular FormulaC16H16FN3
Molecular Weight269.32 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Mizolastine Impurity 8 CAS CATO-C4X-20068 chemical structure

Description

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.

Mizolastine Impurity 8 (CAS CATO-C4X-20068) is a certified pharmaceutical impurity reference standard with the molecular formula C16H16FN3 and a molecular weight of 269.32 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine substitution, Mizolastine Impurity 8 is typically pale yellow to yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 269.32 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC16H16FN3
Molecular Weight269.32 g/mol
Purity97%+
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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms3

Related Mizolastine Standards

Recommended Standards

Why CATO?