Bromhexine Nitroso Impurity 34 NEW

Bromhexine Nitroso Impurity 34

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

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• 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: C₈H₉Br₂N₃O

• Molecular Weight: 322.98

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

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• 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.

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• 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.

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• Current research focuses on:
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• 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