Mirtazapine Impurity 26 CAS CATO-C4X-151126

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Mirtazapine Impurity 26.

CATO supplies Mirtazapine Impurity 26 (CAS CATO-C4X-151126), a pharmacopoeial impurity reference standard (molecular formula C11H15N3O, MW 205.26 g/mol) used for the identification and quantification of trace impurities in APIs.

Mirtazapine Impurity 26 (C11H15N3O) 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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

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