Zolmitriptan Impurity 34;114094-45-0
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E-mail: anna@molcoo.com
Product Number: Z004034
English Name: Zolmitriptan Impurity 34
English Alias: 4,4-diethoxy-N-methylbutan-1-amine
CAS Number: 114094-45-0
Molecular Formula: C₉H₂₁NO₂
Molecular Weight: 175.27
As an impurity of Zolmitriptan, this compound has the following advantages:
Well-defined with distinct functional groups: Contains a diethoxy acetal, N-methylamine, and butane chain, differing from zolmitriptan by lacking the indoline core. Acetal polarity and amine basicity enable clear differentiation via GC or reversed-phase HPLC as a specific impurity marker;
High stability and traceability: Acetal structure is stable under neutral conditions. As an intermediate from incomplete reduction of amino acetal in zolmitriptan synthesis, it directly reflects amine intermediate purity pre-indoline formation, improving process tracing accuracy;
High detection sensitivity: Amine protonation enhances GC response, combined with characteristic mass response (m/z 176 [M+H]⁺), enabling trace analysis (ppb level) via GC-MS, compatible with amino acetal impurity systems.
Pharmaceutical quality control: Used as an impurity reference standard to quantify Zolmitriptan Impurity 34 in APIs, ensuring residual amino acetal intermediates meet quality standards post-reduction/indoline cyclization;
Synthesis optimization: Optimizing acetal reduction (reducing agent dosage) by monitoring impurity levels to enhance indoline ring formation efficiency;
Intermediate purity assessment: Evaluating purity of key amino acetal intermediates in zolmitriptan synthesis to support specificity of downstream cyclization.
Zolmitriptan, a 5-HT receptor agonist for migraine, requires amino acetal reduction and cyclization to form its indoline core. Incomplete acetal reduction may generate uncyclized 4,4-diethoxy-N-methylbutan-1-amine, known as Zolmitriptan Impurity 34. Lacking the active core, it has no pharmacological activity, and its residue risks reducing zolmitriptan purity, making control critical for quality assurance.
Current research focuses on:
Analytical method validation: Developing GC-MS assays with weakly polar columns for baseline separation, achieving 0.5 ppb detection limits;
Reduction kinetics: Studying impurity formation under varying reducing agent concentrations to clarify amino acetal-to-indoline conversion mechanisms;
Process refinement: Controlling impurity levels below 0.1% via optimized catalyst dosage to enhance API purity;
Structural confirmation: Using ¹H/¹³C-NMR to verify acetal/amine structure, distinguishing from zolmitriptan’s indoline core for impurity identification
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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