Atomoxetine Impurity 8 CAS 79130-51-1

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.79130-51-1
Molecular FormulaC11H16ClN
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Atomoxetine Impurity 8 CAS 79130-51-1 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 Atomoxetine Impurity 8.

As a process- or degradation-related impurity, Atomoxetine Impurity 8 (CAS 79130-51-1, C11H16ClNHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Atomoxetine Impurity 8 (C11H16ClNHCl) is characterized by a nitrile group, chlorine substitution. 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC11H16ClN HCl
Molecular Weight234.16 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1979
Halogen ContentCl-containing
Nitrogen Atoms1

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