Amlodipine Impurity 68;2923811-72-5
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E-mail: anna@molcoo.com
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: C₃₆H₃₀ClN₃O₉
Molecular Weight: 684.09
As an impurity of Amlodipine, this compound has the following 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.
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.
Amlodipine, a dihydropyridine calcium channel blocker, requires carboxyl protection (e.g., isoindolinone) and dihydropyridine cyclization in synthesis. Incomplete removal of isoindolinyl groups may generate derivatives with isoindolinones at 3,5-positions and side chain, known as Amlodipine Impurity 68. Lacking deprotection, it has no pharmacological activity, and its residue risks reducing amlodipine purity, making control critical for quality assurance.
Current research focuses on:
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
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