Mosapride Nitroso Impurity
Product Code：M021045
English Name：Mosapride Nitroso Impurity 45
English Alias：N-(3,4-difluorobenzyl)-N-(2-hydroxyethyl)nitrous amide
CAS No.：[Not Available]
Molecular Formula：C₉H₁₀F₂N₂O₂
Molecular Weight：216.18
High-Purity Guarantee：Confirmed by HPLC (≥99.0%), combined with NMR (1H, 13C), HRMS, and elemental analysis, ensuring accuracy and reliability in Mosapride impurity analysis.
Superior Stability：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.2% in acetonitrile - water solution within 6 months, ensuring stable and reproducible experimental data.
Quality Control Testing：Used for UPLC-MS/MS detection of Nitroso Impurity 45 in Mosapride API and formulations, strictly controlling impurity content to meet ICH M7 standards (requirements for genotoxic impurity limits) and ensuring drug quality and safety.
Process Optimization Research：Monitor the formation of N-(3,4-difluorobenzyl)-N-(2-hydroxyethyl)nitrous amide during Mosapride synthesis or storage. Reduce impurity generation by over 60% by adjusting reaction temperature (e.g., 5 - 10℃), optimizing reaction solvents, or minimizing nitrite exposure.
Method Validation：Serves as a standard for developing nitrosamine impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.005 ng/mL) to ensure detection methods meet regulatory requirements.
Mosapride is a prokinetic drug used in the treatment of functional dyspepsia and other gastrointestinal disorders. Mosapride Nitroso Impurity 45, as a potential genotoxic impurity (GTI), may be formed during drug synthesis through nitrosation reactions between nitrogen-containing raw materials and nitrites, or spontaneously under acidic and high-temperature storage conditions. Its nitrosamide group poses mutagenic and carcinogenic risks. With increasingly strict regulations on genotoxic impurities by global regulatory agencies such as FDA and EMA, the study of this impurity has become a crucial part of ensuring the safety and compliance of Mosapride drugs.
Detection Technology：UPLC-MS/MS with a C18 column (1.7μm) and 0.1% formic acid - acetonitrile gradient elution achieves separation within 3 minutes, with an LOD as low as 0.002 ng/mL, enabling highly sensitive detection of trace nitrosamine impurities.
Formation Mechanism：Studies show that this impurity is formed by the reaction of 3,4-difluorobenzylamine, 2-hydroxyethylamine, and sodium nitrite under acidic conditions (pH＜4). It can be effectively inhibited by optimizing the reaction system pH to neutral, using inert gas protection, or replacing the synthesis route without nitrosation risk.
Safety Evaluation：In vitro Ames tests confirm the mutagenicity of this impurity, and toxicological studies determine its permitted daily intake (TTC value) as 1.5 μg/day. Currently, accelerated stability tests are being carried out to systematically monitor its nitrosation rate under different humidity, light, and temperature conditions, aiming to improve risk control strategies.
This product is intended for laboratory use only!
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