Domperidone EP Impurity D NEW

Domperidone EP Impurity D;1614255-34-3

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E-mail: anna@molcoo.com

Product Information

• Product Number: D028006

• English Name: Domperidone EP Impurity D

• English Alias: 5-chloro-3-(3-(2-oxo-2,3-dihydro-1H-benzo[d]imidazol-1-yl)propyl)-1-(1-(3-(2-oxo-2,3-dihydro-1H-benzo[d]imidazol-1-yl)propyl)piperidin-4-yl)-1H-benzo[d]imidazol-2(3H)-one

• CAS Number: 1614255-34-3

• Molecular Formula: C₃₂H₃₄ClN₇O₃

• Molecular Weight: 600.11

Advantages

• Well-defined with distinct disubstitution features: Contains two benzimidazolinone cores (one 5-chloro-substituted), piperidine ring, and bis(3-(benzimidazolinone-1-yl)propyl) side chains. Unlike domperidone (monosubstituted), its bis-benzimidazolinone polarity and conjugation enable clear differentiation via reversed-phase HPLC/LC-MS as a specific impurity marker;

• High stability and traceability: Benzimidazolinone lactam structure and piperidine rigidity ensure stability under neutral conditions. As a piperidine disubstitution byproduct in domperidone synthesis, it directly reflects N-alkylation selectivity, improving process tracing accuracy;

• High detection sensitivity: Strong UV absorption (280-300nm) from bis-benzimidazolinone conjugation, combined with characteristic mass response (m/z 601 [M+H]⁺), enables trace analysis (ppb level) via LC-MS/MS, compatible with benzimidazolinone disubstituted impurity systems.

Applications

• Pharmaceutical quality control: Used as an EP reference standard to quantify Domperidone EP Impurity D in APIs/formulations, ensuring compliance with European Pharmacopoeia (EP) limits for piperidine alkylation impurities;

• Synthesis optimization: Optimizing alkylating reagent dosage and catalyst selectivity by monitoring impurity levels to enhance piperidine monosubstitution efficiency;

• Impurity profile enrichment: Supporting regulatory filings by supplementing domperidone’s impurity profile, enabling compliance with international pharmacopoeial standards.

Background Description

Research Status

• Analytical method validation: Developing UPLC-DAD assays with C18 columns for baseline separation, achieving 0.05% quantitation limits per EP standards;

• Alkylation kinetics: Studying impurity formation under varying solvent polarity to clarify disubstitution mechanisms and inhibition strategies;

• Process refinement: Controlling impurity levels below 0.1% via optimized reagent stoichiometry to meet EP specifications;

• Structural confirmation: Using ¹H/¹³C-NMR and X-ray diffraction to verify disubstitution, distinguishing from domperidone for authoritative 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