Product Number: T023017
English Name: Timolol Impurity 17
English Alias: (S)-N-(tert-butyl)-N-(2-hydroxy-3-((4-morpholino-1,2,5-thiadiazol-3-yl)oxy)propyl)nitrous amide
CAS Number: None
Molecular Formula: C₁₃H₂₃N₅O₄S
Molecular Weight: 345.42
As a nitroso impurity of timolol, the research advantages of this compound lie in:
Analyzing the by-product formation mechanism of nitrosation reactions during timolol synthesis or storage to optimize processes for controlling nitroso impurity generation;
Serving as a reference standard containing nitroso, hydroxyl, thiadiazole, and morpholine structures to provide a standard substance for detecting impurities with complex structures in drugs, assisting in evaluating drug safety (nitroso compounds may have potential carcinogenicity);
Helping study the impact of multi-functional group 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 Impurity 17 in timolol 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.
Timolol is a β-blocker commonly used in the treatment of glaucoma, hypertension, and angina. 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. Timolol Impurity 17, as an impurity containing a nitroso structure, may be generated during timolol synthesis, storage, or metabolism, making research on it a key link in drug quality control and safety assessment.
Current research focuses on:
Synthesis Methods: Developing high-purity synthesis processes for Timolol Impurity 17, solving the synthesis and purification challenges of multi-functional group 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
