Product Certification&
Enterprise Certification
Country: China (Mainland)
Business Type:Lab/Research institutions
Tel: +86-173-20513646
Mobile: 17320513646
Tel: +86-173-20513646
Fax:
Province/state: Hu Bei
City: Wuhan
Street: Company address: Room 005, 15th Floor, Building D2, Phase III, Software New Town, No. 8 Huacheng Avenue, East Lake High-tech Development Zone, Wuhan, Hubei Province, China
MaxCard:
CAS NO.1059182-81-8
1(10.0-10000)Metric Ton
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.
Dobutamine Impurity
Product Information
Product Code:D044043
English Name:Dobutamine Impurity 43
English Alias:N-(3,4-dimethoxyphenethyl)-4-methoxyaniline
CAS No.:1059182-81-8
Molecular Formula:C??H??NO?
Molecular Weight:287.35
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 43 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 condensation temperature (e.g., 60-70℃) and catalyst dosage (e.g., triethylamine).
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 43 may originate from condensation side reactions of arylamines during Dobutamine synthesis. The polymethoxyphenyl group 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 2.5 minutes, with LOD of 0.002 ng/mL for trace analysis.
Formation Mechanism:Formed by condensation of 4-methoxyaniline with 3,4-dimethoxyphenethyl halide under alkaline conditions; optimizing reaction time (≤4h) and solvent polarity (e.g., acetonitrile-water system) inhibits side reactions.
Safety Evaluation:In vitro cytotoxicity shows IC?? of 187.5 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.
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
NEW IN STOCK!
The Molcoo Laboratory added drug impurity reference standards, including Baricitinib, Piperazine, Benzylpenicillin, Tranilast and multiple N-Nitroso drug impurities! Now available for immediate delivery!