Mirtazapine Impurity 29 CAS 5271-29-4

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.5271-29-4
Molecular FormulaC12H18N2
Molecular Weight190.28 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Mirtazapine Impurity 29 CAS 5271-29-4 chemical structure

Description

Mirtazapine Impurity 29 (CAS 5271-29-4) is a certified pharmaceutical impurity reference standard with the molecular formula C12H18N2 and a molecular weight of 190.28 g/mol.

The molecular framework of Mirtazapine Impurity 29 (C12H18N2) is characterized by a nitrogen-containing heterocyclic scaffold, a nitrile group. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.

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 FormulaC12H18N2
Molecular Weight190.28 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)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1958
Nitrogen Atoms2

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