Keywords

• 2361294-43-9
• drug impurity
• N-nitroso paroxetine

Quick Details

• ProName: N-nitroso paroxetine
• CasNo: 2361294-43-9
• Molecular Formula: C19H19FN2O4
• Appearance: solid
• Application: for drug impurity for drug standards,f...
• DeliveryTime: 1-2 weeks
• PackAge: 10mg/25mg/50mg/100mg/1000mg/5000mg
• Port: SHENZHEN or SHANGHAI
• ProductionCapacity: 5000 Metric Ton/Year
• Purity: 95%+ or 98%+
• Storage: short-term storage normal temperature....
• Transportation: express and sea transport and air frei...
• LimitNum: 25 Milligram
• Moisture Content: within 3%
• Impurity: within 5%

Superiority

Our products are mainly drug impurity reference products, drug standards, analytical chemistry, standard substances, organic chemical synthesis, chemical custom synthesis. For impurity localization, quantification, and quality control in drug development processes. Our laboratory area is more than 5000 square meters, we have more than 20 analytical instruments such as HPLC and MS/LC-MS/GC-MS, we also have TGA, IR and other testing instruments. We have the most advanced SFC preparation separation equipment. We can provide a full range of impurity reference/standard products required for drug development. Most of the impurities are synthesized through the process, there are also many items of impurities can not be obtained by synthetic means, need to be obtained through raw materials, intermediates, crude products or side reactions contained in the trace target compounds, Hubei Moke has a professional impurity preparation and separation technology team, equipped with professional SFC preparation and separation equipment. It can carry out efficient and accurate separation of impurities for complex projects, and solve the problem of impurity preparation for customers.
 

1. We integrate R&D, production and sales. A 5,000-square-meter high-standard bio-intelligent manufacturing base can ensure high quality and fast delivery of products. The professional sales team ensures that you don't need to worry about pre-sales and after-sales.

2. We focus on pharmaceutical standards, pharmaceutical intermediates, pharmaceutical impurity controls, peptide customization, our own laboratory, and undertake customized synthesis projects.

3. We offer products from gram grade to g grade, in addition, some product specifications and packaging can be customized.

4. We have been deeply engaged in the pharmaceutical field for ten years and have rich experience. At present, customers are all over the world, and have been highly recognized and trusted by customers.

5. We can provide a variety of safe ways to transport goods for you to choose.

Details

N-Nitroso Paroxetine

Product Information

• Product Code：N031201

• English Name：N-Nitroso Paroxetine

• English Alias：(3S,4R)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4-fluorophenyl)-1-nitrosopiperidine

• CAS No.：2361294-43-9

• Molecular Formula：C19H19FN2O4

• Molecular Weight：358.36

Advantages

• High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), combined with NMR (1H, 13C), HRMS, and X-ray single-crystal diffraction, ensuring the accuracy and reliability of impurity analysis.

• Excellent Stability：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.1% in acetonitrile - water solution within 6 months, guaranteeing stable and reproducible experimental data.

Applications

• Quality Control Testing：Used for UPLC - MS/MS detection of N-nitroso impurities in Paroxetine API and formulations, strictly controlling impurity content to meet ICH M7 standards (genotoxic impurity limit ≤1.5 μg/day).

• Process Optimization Research：Monitor the formation of N - Nitroso Paroxetine during Paroxetine synthesis or storage. Reduce impurity generation by over 60% by adjusting reaction temperature (e.g., 5 - 10℃), avoiding nitrite-containing substances, or adding antioxidants.

• Method Validation：Serves as a standard for developing nitrosamine impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.005 ng/mL) to meet regulatory requirements for detection methods.

Background Description

Paroxetine is a selective serotonin reuptake inhibitor widely used in the treatment of mental disorders such as depression and obsessive-compulsive disorder. N - Nitroso Paroxetine, as a potential genotoxic impurity (GTI), may be formed by the reaction between the piperidine structure and nitrites during Paroxetine production or through spontaneous nitrosation under acidic and high - temperature storage conditions. Its nitrosamine 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 drug safety and compliance.

Research Status

• Detection Technology：UPLC - MS/MS with a C18 column (1.7μm) and 0.1% formic acid - acetonitrile gradient elution achieves separation within 4 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 the piperidine nitrogen atom in Paroxetine with 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.