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

Domperidone EP Impurity E NEW

Price Get Latest Price
Package 10mg 50mg 100mg
Min. Order: 10mg
Supply Ability: 1000
Update Time: 2025-07-24

Product Details

Product Name: Domperidone EP Impurity E CAS No.: 1346602-50-3
Min. Order: 10mg Purity: 99%+ HPLC
Supply Ability: 1000 Release date: 2025/07/24
Molecular formula: C32H34ClN7O3

Domperidone EP Impurity D;1346599-76-5

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

Product Information

  • Product Number: D028007

  • English Name: Domperidone EP Impurity E

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

  • CAS Number: 1346602-50-3

  • 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 tricyclic features: Contains three benzimidazolinone cores (one 5-chloro-substituted), piperidine ring, and bis(3-benzimidazolylpropyl) side chains, differing from domperidone by an additional benzimidazolinone ring. The tricyclic conjugated system enables clear differentiation via reversed-phase HPLC/LC-MS as a specific impurity marker;

  • High stability and traceability: Tricyclic lactam structures and piperidine rigidity ensure stability under neutral conditions. As an over-coupling byproduct in domperidone synthesis, it directly reflects excessive N-alkylation, improving process tracing accuracy;

  • High detection sensitivity: Strong UV absorption (270-290nm) from tricyclic conjugation, combined with characteristic mass response (m/z 601 [M+H]?), enables trace analysis (ppb level) via LC-MS/MS, compatible with polycyclic benzimidazolinone impurity systems.

Applications

  • Pharmaceutical quality control: Used as an EP reference standard to quantify Domperidone EP Impurity E in APIs/formulations, ensuring compliance with EP standards for benzimidazolinone-piperidine coupling impurities;

  • Synthesis optimization: Optimizing reagent ratios and reaction time by monitoring impurity levels to reduce over-coupling and enhance target monocyclic coupling efficiency;

  • Impurity profile enrichment: Supporting regulatory filings by supplementing domperidone’s impurity profile to meet international pharmacopoeial requirements.

Background Description

Domperidone, a prokinetic agent, consists of 5-chlorobenzimidazolinone, piperidine, and a single side chain. Poorly controlled coupling (e.g., excess reagents) may cause multi-step conjugation, generating tricyclic benzimidazolinone derivatives like Domperidone EP Impurity E. Pharmacologically inactive and listed as a controlled impurity in EP, its control is critical for domperidone quality assurance.

Research Status

Current research focuses on:


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

  • Coupling kinetics: Studying impurity formation under varying reaction durations to clarify over-conjugation mechanisms and inhibition strategies;

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

  • Structural confirmation: Using 2D-NMR and HRMS to verify tricyclic structure, 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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