Keywords

• 2,3-Difluorobrmorobenzene
• Rimegepant Impurity
• 38573-88-5

Quick Details

• ProName: Rimegepant Impurity ;38573-88-5
• CasNo: 38573-88-5
• Molecular Formula: C6H3BrF2
• 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

Rimegepant Impurity

Product Information

• Product Code：R046076

• English Name：Rimegepant Impurity 76

• English Alias：1-bromo-2,3-difluorobenzene

• CAS No.：38573-88-5

• Molecular Formula：CHBrF

• Molecular Weight：192.99

Advantages

• High-Purity Guarantee：Confirmed by HPLC (≥99.0%), combined with multiple techniques such as NMR (1H, 13C), HRMS, and elemental analysis, providing an accurate standard for Rimegepant impurity analysis.

• Good Stability：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.2% in common organic solvents (such as acetonitrile, toluene) within 6 months, ensuring stable and reliable experimental data.

Applications

• Quality Control Testing：Used for UPLC-MS/MS or GC-MS detection of Impurity 76 in Rimegepant API and formulations, strictly controlling impurity content to meet ICH Q3A and Q3B standards (single impurity limit ≤0.1%).

• Process Optimization Research：Monitor the residue or formation of 1-bromo-2,3-difluorobenzene during Rimegepant synthesis. Reduce impurity residue by over 60% by adjusting the halogenation reaction temperature (e.g., 0 - 5℃), reaction time, and raw material ratio.

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

Background Description

Rimegepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, is used for treating migraines. Impurity 76 (1-bromo-2,3-difluorobenzene) may remain as a raw material or be generated during synthesis steps such as halogenation and substitution. Its bromine and fluorine atoms may affect the drug's stability, safety, and subsequent metabolism. With the increasing strict requirements of global regulatory agencies (such as FDA and EMA) for drug impurities, the study of this impurity has become a crucial part of ensuring the quality of Rimegepant drugs and patient safety.

Research Status

• Detection Technology：High-sensitivity GC-MS/MS technology, equipped with a DB-5MS column (30m×0.25mm×0.25μm) and selected ion monitoring (SIM) mode, achieves separation within 5 minutes, with an LOD as low as 0.002 ng/mL, enabling precise detection of trace impurities.

• Formation Mechanism：Studies indicate that this impurity is mainly formed during the benzene ring halogenation reaction. Excessive reaction temperature or an excess of brominating and fluorinating agents will increase its content. It can be effectively inhibited by optimizing reaction conditions, such as using a low-temperature dropwise addition method and precisely controlling reagent dosages.

• Safety Evaluation：In vitro cytotoxicity tests show that the IC of this impurity against HEK293 cells is 210.5 μM (Rimegepant IC = 15.2 μM). Although less toxic than the main drug, its content in drugs still requires strict control. Currently, long-term stability tests are being carried out to systematically monitor its stability under different humidity, light, and temperature conditions.