Keywords

• Rizatriptan EP Impurity A
• Rizatriptan
• C28H35N7·2HCl

Quick Details

• ProName: Rizatriptan EP Impurity A;C28H35N7·2HC...
• Molecular Formula: C28H35N7·2HCl
• Appearance: White to off white powder
• Application: for drug impurity for drug standards,f...
• DeliveryTime: 1-2 weeks
• PackAge: 10mg/25mg/50mg/100mg/1000mg/5000mg
• Port: Shenzhen/hongkong
• ProductionCapacity: 5000 Metric Ton/Day
• Purity: 95%+ or 98%+
• Storage: -20℃
• LimitNum: 25 Milligram
• Moisture Content: 0.1%
• Impurity: 0.1%

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

Rizatriptan EP Impurity A(Dihydrochloride)

Product Information

• Product Code：R047002A

• English Name：Rizatriptan EP Impurity A(Dihydrochloride)

• English Alias：2-(5-((1H-1,2,4-triazol-1-yl)methyl)-2-((3-(2-(dimethylamino)ethyl)-1H-indol-5-yl)methyl)-1H-indol-3-yl)-N,N-dimethylethanamine dihydrochloride

• CAS No.：[Not Available]

• Molecular Formula：CHN·2HCl

• Molecular Weight：542.54（469.62 + 2×36.46）

Advantages

• Ultra-High Purity：Confirmed by HPLC (≥99.5%), combined with NMR (1H, 13C), HRMS, and elemental analysis, ensuring accuracy and reliability in impurity analysis.

• Excellent Stability：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.1% in acetonitrile-water (1:1) solution within 6 months, ensuring high reproducibility of experimental data.

Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of EP Impurity A (dihydrochloride) in Rizatriptan API and formulations, controlling impurity content to meet EP standards (single impurity limit ≤0.1%).

• Process Optimization Research：Monitors the formation pathway of this impurity during Rizatriptan synthesis, reducing generation by over 50% by adjusting condensation reaction temperature (e.g., 80-90℃) and reaction time.

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

Background Description

Rizatriptan, a 5-hydroxytryptamine receptor agonist, is used for treating migraines. Impurity A (dihydrochloride), as an EP-specified impurity of Rizatriptan, may be generated during multi-step synthesis due to incomplete alkylation of the indole ring or connection of the triazole ring. Its complex bis-indole structure and dimethylamino group may affect drug stability and safety. With the stricter control requirements of EMA for European Pharmacopoeia impurities, the study of this impurity has become a key link in drug registration and production.

Research Status

• Detection Technology：UPLC-MS/MS with a C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 6 minutes, with an LOD of 0.002 ng/mL, meeting the needs of trace analysis.

• Formation Mechanism：Studies have shown that this impurity is formed by the reaction of 3-(2-dimethylaminoethyl)indole with 1,2,4-triazole methylation reagents under alkaline conditions (e.g., potassium carbonate catalysis). Optimizing the solvent system (such as using DMF instead of ethanol) can inhibit side reactions.

• Safety Evaluation：In vitro cytotoxicity experiments show that the IC of this impurity against SH-SY5Y cells is 189.3 μM (Rizatriptan IC = 12.6 μM). Although less toxic than the main drug, its content in drugs still needs to be strictly controlled. Currently, long-term stability tests are being conducted to monitor its degradation behavior.