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Postion:Product Catalog >Domperidone EP Impurity D
Domperidone EP Impurity D
  • Domperidone EP Impurity D
  • Domperidone EP Impurity D
  • Domperidone EP Impurity D
  • Domperidone EP Impurity D
  • Domperidone EP Impurity D

Domperidone EP Impurity D NEW

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Package 10mg 50mg 100mg
Min. Order: 10mg
Supply Ability: 1000
Update Time: 2025-07-22

Product Details

Product Name: Domperidone EP Impurity D CAS No.: 1614255-34-3
Min. Order: 10mg Purity: 99%+ HPLC
Supply Ability: 1000 Release date: 2025/07/22
Molecular formula: C32H34ClN7O3

Domperidone EP Impurity D;1614255-34-3

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WhatsAPP: +86 17386083646
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: C??H??ClN?O?

  • Molecular Weight: 600.11

Advantages

As a specific impurity of Domperidone (EP-specified), this compound has the following 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

Domperidone, a benzimidazolinone prokinetic agent, features a monosubstituted piperidine and 5-chlorobenzimidazolinone. Poorly controlled N-alkylation (e.g., excess alkylating agent) may generate disubstituted derivatives with benzimidazolylpropyl groups on both piperidine and benzimidazolinone, known as Domperidone EP Impurity D. Structurally distinct, it risks altering bioavailability and is listed as a controlled impurity in EP, making control critical for quality assurance.

Research Status

Current research focuses on:


  • 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








Company Profile Introduction

1. Drug standards and drug impurity reference substances: provide more than 20,000 kinds of spot impurity reference substances, with sufficient supply and same-day delivery. We have a professional R&D team and comprehensive quality control testing to ensure product quality and reliability. 2. Customized synthesis of impurities and new molecules: Quickly respond to the customized needs of CDE impurities, stably supply impurities that have established quality standards, and provide customized synthesis services for new compounds in the research and development of innovative drugs. 3. Preparation and separation of unknown impurities: With a professional impurity preparation and separation technical team and SFC preparation and separation instruments, we can solve the problems of impurity preparation in complex projects. 4. Process development of new drug intermediates: provide the supply of new drugs and new molecular impurities, process optimization services, as well as the screening and impurity analysis of commercialization routes. 5. Peptide synthesis: Provide customized peptide synthesis services, and cover all kinds of degradation impurities and process impurities generated in the research and development of peptide drugs. At the same time, it provides comprehensive structural confirmation data and customized testing services.

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