Chlorphenamine Impurity C NEW

Product Information

• Product Number: C046002A

• English Name: Chlorphenamine Impurity C

• English Alias: 3-(4-chlorophenyl)-N-methyl-3-(pyridin-2-yl)propan-1-amine

• CAS Number: None

• Molecular Formula: C₁₅H₁₇ClN₂

• Molecular Weight: 260.76

Advantages

• Well-defined with distinct functional groups: Contains 3-(4-chlorophenyl)-3-(pyridin-2-yl)propane skeleton and N-methylamine structure. Unlike chlorphenamine (antihistamine with N,N-dimethyl tertiary amine), its secondary amine polarity, chlorine electronegativity, and pyridine aromaticity create significant differences, enabling precise differentiation via HPLC/ion-exchange chromatography as a specific marker;

• High stability and traceability: Rigid benzene/pyridine rings and stability of C-N bonds ensure neutral-condition stability. As a byproduct from incomplete methylation in synthesis or demethylation in metabolism, it directly reflects methylation efficiency or metabolic pathways, improving process and metabolic tracing accuracy;

• High detection sensitivity: Benzene-pyridine conjugation shows strong UV absorption (250-280nm), combined with m/z 261 [M+H]⁺ enabling ppb-level analysis via LC-MS, compatible with antihistamine amine impurity systems.

Applications

• Pharmaceutical quality control: Used as an impurity reference standard to quantify Chlorphenamine Impurity C in APIs, ensuring residual monomethylated byproducts meet quality standards;

• Synthesis optimization: Optimizing methylation conditions (reagent dosage) by monitoring impurity levels to enhance N,N-dimethylation specificity and reduce monomethyl byproducts;

• Metabolism studies: Analyzing in vivo metabolic pathways of chlorphenamine to confirm if demethylation is a major route, supporting drug disposition and safety assessment.

Background Description

Research Status

• Analytical method validation: Developing HPLC assays with C18 columns for separation, achieving 0.1 ppb detection limits;

• Methylation kinetics: Studying impurity formation under varying methylating agent concentrations to clarify mono-to-dimethylation pathways;

• Control strategies: Optimizing methylation parameters (excess reagent) to keep impurity levels below 0.1% and enhance API purity;

• Structural confirmation: Using ¹H/¹³C-NMR and mass spectrometry to verify secondary amine structure, distinguishing from chlorphenamine for authoritative identification