Product Number: N031080
English Name: N-Nitroso Desmethyl Cidoxepin
English Alias: (Z)-N-(3-(dibenzo[b,e]oxepin-11(6H)-ylidene)propyl)-N-methylnitrous amide
CAS Number: None
Molecular Formula: C₁₈H₁₈N₂O₂
Molecular Weight: 294.35
As a nitroso impurity of desmethyl cidoxepin, the research advantages of this compound lie in:
Analyzing the by-product formation mechanism of nitrosation reactions during cidoxepin metabolism or synthesis to optimize processes for controlling nitroso impurity generation;
Serving as a nitroso-class reference standard to provide a standard substance for detecting nitroso impurities in drugs, assisting in evaluating 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 cidoxepin preparations, evaluating the purity of APIs and metabolites;
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.
Cidoxepin is an antidepressant drug, and its metabolites or synthesis may produce nitroso compounds. N-Nitroso Desmethyl Cidoxepin, as an impurity containing a nitroso structure, may be generated during demethylation reactions or storage. Due to the potential carcinogenic risk of nitroso compounds (such as N-nitrosamines), drug regulatory authorities worldwide have put forward strict control requirements for such impurities in drugs, making research on this impurity a key link in drug quality control and safety assessment.
Current research focuses on:
Synthesis Methods: Developing high-purity synthesis processes for (Z)-configured 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
China
