Milnacipran Impurity 41 HCl (Mixture of Enantiomers) CAS CATO-C4X-103341

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-103341
Molecular FormulaC15H20N2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Milnacipran Impurity 41 HCl (Mixture of Enantiomers) CAS CATO-C4X-103341 chemical structure

Description

The molecular framework of Milnacipran Impurity 41 HCl (Mixture of Enantiomers) (C15H20N2HCl) is characterized by a nitrogen-containing heterocyclic scaffold, 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. 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).

As a process- or degradation-related impurity, Milnacipran Impurity 41 HCl (Mixture of Enantiomers) (CAS CATO-C4X-103341, C15H20N2HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

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 FormulaC15H20N2 HCl
Molecular Weight264.80 g/mol
Purity≥95%
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)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms2

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