Keywords

• Brexpiprazole Impurity K
• drug impurities
• drug standards

Quick Details

• ProName: Brexpiprazole Impurity K
• CasNo: 2116542-21-1
• Molecular Formula: C38H40N4O4S
• Appearance: solid
• Application: for drug impurities, for drug standard...
• 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

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

Brexpiprazole Impurity K

Product Information

• Product Code：B007032

• English Name：Brexpiprazole Impurity K

• English Alias：7-(4-((7-(4-(4-(benzo[b]thiophen-4-yl)piperazin-1-yl)butoxy)quinolin-2-yl)oxy)butoxy)quinolin-2(1H)-one

• CAS No.：2116542-21-1

• Molecular Formula：C38H40N4O4S

• Molecular Weight：648.81

Advantages

• Ultra-High Purity：Confirmed by HPLC (≥99.5%), along with NMR (1H, 13C), HRMS, and X-ray single-crystal diffraction, 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 solution within 6 months, providing outstanding reproducibility of experimental data.

Applications

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

• Process Optimization Research：Monitor the formation pathway of Impurity K during Brexpiprazole synthesis. Reduce impurity generation by over 60% by adjusting the condensation reaction temperature (e.g., 60 - 70℃), reaction time, and catalyst dosage.

• Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.5) and LOD (0.003 ng/mL) to ensure compliance with regulatory requirements.

Background Description

Brexpiprazole is an atypical antipsychotic drug used for treating schizophrenia and depression. Impurity K, as a specific process-related impurity, may arise from incomplete intermediate reactions, side reactions, or raw material residues during multi-step synthesis. Its complex quinoline and benzo[b]thiophene structure may affect the drug's stability, safety, and efficacy. With increasingly strict regulations on drug impurities by international regulatory agencies such as FDA and EMA, the study of Brexpiprazole Impurity K is crucial for ensuring drug quality and patient safety.

Research Status

• Detection Technology：UPLC-MS/MS with a C18 column (1.7μm) and 0.1% formic acid - acetonitrile gradient elution achieves separation within 5 minutes, with an LOD as low as 0.001 ng/mL, enabling highly sensitive detection of trace impurities.

• Formation Mechanism：Studies indicate that Impurity K mainly forms during piperazine ring attachment and quinoline ring etherification steps. Optimizing the reaction solvent system (e.g., using DMF instead of methanol) and controlling raw material ratios can effectively suppress its formation.

• Safety Evaluation：In vitro cytotoxicity tests show that the IC?? of Impurity K against SH-SY5Y nerve cells is 156.8 μM (Brexpiprazole IC?? = 8.7 μM). Although less toxic than the main drug, its content in drugs still requires strict control. Long-term stability testing is currently underway to systematically monitor its degradation behavior under different humidity, light, and temperature conditions.

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!

WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com

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