Keywords

• 3-hydroxy-4-methoxyphenylacetonitrile
• Dobutamine Impurity
• 4468-58-0

Quick Details

• ProName: Dobutamine Impurity 4468-58-0
• CasNo: 4468-58-0
• Molecular Formula: C9H9NO2
• 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

Dobutamine Impurity

Product Information

• Product Code：D044044

• English Name：Dobutamine Impurity 44

• English Alias：2-(3-hydroxy-4-methoxyphenyl)acetonitrile

• CAS No.：4468-58-0

• Molecular Formula：CHNO

• Molecular Weight：163.17

Advantages

• High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), and HRMS, suitable for precise analysis of Dobutamine impurities.

• Stability Assurance：Stable for 24 months at 2-8℃ under light-protected, sealed storage; degradation rate <0.3% in methanol solution within 1 month.

Applications

• Quality Control Testing：Used for HPLC and LC-MS detection of Impurity 44 in Dobutamine API and formulations, controlling impurity content to meet ICH Q3A standards (≤0.1%).

• Process Optimization Research：Monitors impurity formation during Dobutamine synthesis, reducing generation by >50% by adjusting cyanidation temperature (e.g., 25-30℃) and cyanide reagent dosage.

• Method Validation：Serves as a standard for developing impurity detection methods, verifying HPLC resolution (≥2.0) and LOD (0.01 ng/mL).

Background Description

Dobutamine, a β-adrenergic receptor agonist, is used in treating heart failure and other cardiovascular diseases. Impurity 44 may originate from cyanidation side reactions of phenolic compounds during Dobutamine synthesis. The hydroxyl and methoxy groups in its structure may affect drug stability and efficacy. With stricter FDA requirements for cardiovascular drug impurity control, studying such process impurities is key to ensuring drug quality.

Research Status

• Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 2 minutes, with LOD of 0.002 ng/mL for trace analysis.

• Formation Mechanism：Formed by reaction of 3-hydroxy-4-methoxybenzaldehyde with sodium cyanide under alkaline conditions; optimizing reaction pH (8.0-9.0) and time (≤3h) inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC of 205.6 μM against H9c2 cardiac cells (Dobutamine IC=15.6 μM), with low toxicity but requiring ≤0.1% limit. Long-term stability testing is ongoing for degradation monitoring.