Mizolastine impurity 12 CAS CATO-C4X-200612

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-200612
Molecular FormulaC21H25FN6
Molecular Weight380.46 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Mizolastine impurity 12 CAS CATO-C4X-200612 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 Mizolastine impurity 12.

Mizolastine impurity 12 (CAS CATO-C4X-200612) is a certified pharmaceutical impurity reference standard with the molecular formula C21H25FN6 and a molecular weight of 380.46 g/mol.

Structurally, Mizolastine impurity 12 (C21H25FN6) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 12.0, corresponding to approximately 12 ring(s) or double-bond equivalent(s). With a molecular weight of 380.46 g/mol, it falls into the moderately-high-molecular-weight range. 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.

CATO manufactures Mizolastine impurity 12 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC21H25FN6
Molecular Weight380.46 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at 2-8°C, 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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms6

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