Mosapride Nitroso Impurity NEW

Mosapride Nitroso Impurity

Product Information

• 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

Advantages

• 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.

Applications

• 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.

Background Description

Research Status

• 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.

We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.

This product is intended for laboratory use only!

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E-mail: anna@molcoo.com

NEW IN STOCK!

The Molcoo Laboratory added drug impurity reference standards, including Baricitinib, Piperazine, Benzylpenicillin, Tranilast and multiple N-Nitroso drug impurities! Now available for immediate delivery!