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Postion:Product Catalog >Lidocaine Impurity 53
Lidocaine Impurity 53
  • Lidocaine Impurity 53
  • Lidocaine Impurity 53
  • Lidocaine Impurity 53
  • Lidocaine Impurity 53
  • Lidocaine Impurity 53

Lidocaine Impurity 53 NEW

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Package 10mg 50mg 100mg
Min. Order: 10mg
Supply Ability: 1000
Update Time: 2025-07-31

Product Details

Product Name: Lidocaine Impurity 53 CAS No.: 34604-55-2
Min. Order: 10mg Purity: 99%+ HPLC
Supply Ability: 1000 Release date: 2025/07/31
Molecular formula: C14H22N2O2

Lidocaine Impurity 53;34604-55-2

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

  •  scientific basis for formulating reasonable impurity limit standards and ensuring the safety of lidocaine drugs.

  • Product Information

  • Product Number: L017053

  • English Name: Lidocaine Impurity 53

  • English Alias: 2-(diethylamino)-N-(3-hydroxy-2,6-dimethylphenyl)acetamide

  • CAS Number: 34604-55-2

  • Molecular Formula: C??H??N?O?

  • Molecular Weight: 250.34

  • Advantages

  • As an impurity reference standard for lidocaine, this compound has a well-defined structure and stable properties, serving as a standard substance for drug research, development, and quality control. Its advantages include:

  • Enabling precise analysis of the side reaction mechanism of hydroxyl substitution positional isomerization during lidocaine synthesis to optimize processes and reduce the generation of 3-hydroxy impurities;

  • As a polar impurity reference standard containing hydroxyl and acetamide groups, improving the separation and quantitative accuracy of HPLC and other detection methods for positional isomeric impurities;

  • Helping study the impact of hydroxyl position changes on drug stability and toxicological properties to provide a scientific basis for impurity control strategies.

  • Applications

  • Drug Development: Used as an impurity reference standard to identify and quantify 3-hydroxy isomeric impurities in lidocaine and its formulations, evaluating the purity of APIs and formulations;

  • Quality Control: Acting as a standard substance to validate the specificity of detection methods (e.g., HPLC, LC-MS), ensuring the impurity content meets pharmacopoeia requirements during production;

  • Process Optimization: Guiding the optimization of phenolic hydroxyl substitution reaction conditions (such as temperature, catalyst) in the synthesis route by analyzing the formation path of this impurity to reduce impurity generation.

  • Background Description

  • Lidocaine is a commonly used local anesthetic in clinical practice. If the phenolic hydroxyl position in its molecular structure undergoes isomerization (such as 3-hydroxy substitution), Lidocaine Impurity 53 is easily generated. In drug synthesis, insufficient raw material purity or out-of-control electrophilic substitution reaction conditions may lead to the production of this impurity. Since positional isomeric impurities may affect the pharmacological activity and safety of drugs, research on them is an important part of the lidocaine quality control system.
  • Research Status

  • Current research focuses on:

  • Detection Method Optimization: Using HPLC-UV or LC-MS combined techniques to improve the resolution of 3-hydroxy and 4-hydroxy impurities by optimizing chromatographic conditions (such as mobile phase polarity, column temperature);

  • Synthesis Mechanism Research: Tracking the regioselectivity of hydroxyl substitution reactions through isotope labeling to develop highly regioselective synthesis processes;

  • Toxicological Evaluation: Comparing the safety differences between this impurity and lidocaine through in vitro cytotoxicity experiments to provide data support for setting impurity limits;

  • Stability Studies: Investigating the degradation behavior of this impurity under acidic/alkaline conditions to evaluate its impact on the stability of lidocaine injections.

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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