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Postion:Product Catalog >Bromhexine Nitroso Impurity 34
Bromhexine Nitroso Impurity 34
  • Bromhexine Nitroso Impurity 34
  • Bromhexine Nitroso Impurity 34
  • Bromhexine Nitroso Impurity 34
  • Bromhexine Nitroso Impurity 34
  • Bromhexine Nitroso Impurity 34

Bromhexine Nitroso Impurity 34 NEW

Price Get Latest Price
Package 10mg 50mg 100mg
Min. Order: 10mg
Supply Ability: 1000
Update Time: 2025-07-17

Product Details

Product Name: Bromhexine Nitroso Impurity 34 Min. Order: 10mg
Purity: 99%+ HPLC Supply Ability: 1000
Release date: 2025/07/17
Molecular formula: C8H9Br2N3O

Bromhexine Nitroso Impurity 34

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


  • Product Number: B008034

  • English Name: Bromhexine Nitroso Impurity 34

  • English Alias: N-(2-amino-3,5-dibromobenzyl)-N-methylnitrous amide

  • CAS Number: None

  • Molecular Formula: C?H?Br?N?O

  • Molecular Weight: 322.98


  • As a nitroso impurity reference standard for bromhexine, this compound has the following advantages:

  • Well-defined structure and high stability, which can be used to analyze the by-product formation mechanism of nitrosation reactions during bromhexine synthesis or storage, optimizing processes to control nitroso impurity generation;

  • Serving as a reference standard containing nitroso, amino, and dibromophenyl structures, providing a standard substance for detecting nitroso impurities in drugs, and helping to evaluate drug safety (nitroso compounds may have potential carcinogenicity);

  • Helping study the impact of nitroso structures on drug stability and toxicological properties to provide a scientific basis for formulating impurity control strategies.


  • Drug Development: Used as an impurity reference standard to identify and quantify N-nitroso impurities in bromhexine preparations, evaluating the purity of APIs and formulations;

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

  • Toxicological Research: Assisting in evaluating the potential genotoxicity of nitroso impurities to provide data support for drug safety evaluation.


  • Bromhexine is a commonly used expectorant for treating respiratory diseases. Due to the potential carcinogenic risk of nitroso compounds (such as N-nitrosamines), drug regulatory authorities worldwide have put forward strict control requirements for nitroso impurities in drugs. Bromhexine Nitroso Impurity 34, as an impurity with a nitroso structure in bromhexine, may be generated during synthesis, storage, or metabolism. Therefore, research on it is a key link in drug quality control and safety assessment.

  • Current research focuses on:

  • Synthesis Methods: Developing high-purity synthesis processes for Bromhexine Nitroso Impurity 34, solving the challenge of poor stability of nitroso compounds to meet the needs of toxicological research and quality control;

  • Detection Technologies: Establishing trace detection methods for nitroso impurities (detection limits reach ppb level) using ultra-high-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) and other technologies;

  • Toxicological Evaluation: Studying the potential mutagenicity and carcinogenicity of this impurity through in vitro Ames tests and animal models;

  • Process Control: Analyzing the inducements (such as raw material residues, reaction conditions) of nitrosation reactions to optimize the synthesis route or storage conditions to reduce the generation of nitroso impurities

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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