Amlodipine Impurity 68;2923811-72-5

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E-mail: anna@molcoo.com

Product Information

• Product Number: A004068

• English Name: Amlodipine Impurity 68

• English Alias: 3-(2-(1,3-dioxoisoindolin-2-yl)ethyl) 5-methyl 4-(2-chlorophenyl)-2-((2-(1,3-dioxoisoindolin-2-yl)ethoxy)methyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate

• CAS Number: 2923811-72-5

• Molecular Formula: C??H??ClN?O?

• Molecular Weight: 684.09

Advantages

• Well-defined and distinct structure: Retains amlodipine’s 1,4-dihydropyridine core, 2-chlorophenyl, and methyl substituents, with key differences in 3,5-carboxylate esters (2-(1,3-dioxoisoindolin-2-yl)ethyl/methyl) and 2-side chain (same isoindolinone group). Strong polarity and UV activity of multiple isoindolinones enable clear differentiation from amlodipine via reversed-phase HPLC/LC-MS as a specific impurity marker;

• High stability and traceability: Lactam structure of isoindolinones ensures stability under neutral conditions. As a derivative from incomplete deprotection of isoindolinyl protecting groups in amlodipine synthesis, it directly reflects carboxyl protection efficiency, improving process tracing accuracy;

• High detection sensitivity: UV absorption (230-250nm) from conjugated isoindolinones and dihydropyridine, combined with characteristic mass response (m/z 685 [M+H]?), enables trace analysis (ppb level) via LC-MS/MS, compatible with multi-protected dihydropyridine impurity systems.

Applications

• Pharmaceutical quality control: Used as an impurity reference standard to quantify Amlodipine Impurity 68 in APIs, ensuring residual isoindolinyl-protected intermediates meet quality standards post-deprotection/dihydropyridine synthesis;

• Synthesis optimization: Optimizing isoindolinone deprotection (amine reagent dosage) and dihydropyridine condensation by monitoring impurity levels to enhance target product selectivity;

• Intermediate purity assessment: Evaluating purity of key isoindolinyl-protected dihydropyridine intermediates in amlodipine synthesis to support specificity of downstream deprotection/salt formation.

Background Description

Research Status

• Analytical method validation: Developing UPLC-MS/MS assays with C18 columns and isoindolinone fragment monitoring, achieving 0.1 ppb detection limits for baseline separation;

• Deprotection kinetics: Studying impurity formation under varying amine concentrations to clarify isoindolinyl group removal mechanisms;

• Process refinement: Controlling impurity levels below 0.05% via optimized deprotection pH to enhance API purity;

• Structural characterization: Using 2D-NMR to confirm multiple isoindolinone substitutions, supporting structural differentiation from amlodipine.

We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!

WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com