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Country: China (Mainland)
Business Type:Lab/Research institutions
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Tel: +86-173-20513646
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CAS NO.1581285-28-0
1(0.1-10)Metric Ton
Advantages: As a reference standard for Mirabegron Impurity 5, it has a clear chemical structure and high purity, with strict quality testing and identification. It has good stability under different storage conditions and experimental environments. It can be used as a reliable reference substance for the impurity detection of mirabegron bulk drugs and formulations, ensuring the accuracy and repeatability of detection results, meeting the strict requirements of drug research, development, production, and quality supervision, and helping to precisely control drug quality.
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.
Mirabegron Impurity
Product Information
Product Number: M005005
English Name: Mirabegron Impurity 5
English Alias: 1154949-80-0(free base);N-(4-nitrophenethyl)-2-phenylethanamine hydrochloride
CAS Number: 1581285-28-0
Molecular Formula: C16H18N2O2.HCl
Molecular Weight: 306.79
Advantages: As a reference standard for Mirabegron Impurity 5, it has a clear chemical structure and high purity, with strict quality testing and identification. It has good stability under different storage conditions and experimental environments. It can be used as a reliable reference substance for the impurity detection of mirabegron bulk drugs and formulations, ensuring the accuracy and repeatability of detection results, meeting the strict requirements of drug research, development, production, and quality supervision, and helping to precisely control drug quality.
Applications: It is mainly used in the quality research, impurity analysis, and quality control of mirabegron bulk drugs and formulations. It is used to establish and validate impurity detection methods such as high-performance liquid chromatography (HPLC) and liquid chromatography - mass spectrometry (LC - MS). In the research and development process of mirabegron, it is used to study the source and formation mechanism of this impurity, and optimize the synthesis process to reduce impurity generation. In the production process, it is used to monitor the content of Impurity 5 in products in real-time to ensure that drug quality meets relevant standards and regulatory requirements. It can also be used to evaluate the changes of impurities in mirabegron drugs during storage and transportation, providing data support for drug stability research.
Background Description: Mirabegron is a drug used for the treatment of overactive bladder. In the process of its research and development and production, the presence of impurities may affect the safety, effectiveness, and stability of the drug. To ensure the safety of patients' medication and meet the requirements of drug regulation, strict research and precise control of impurities in mirabegron are essential. As one of the impurities of mirabegron, in-depth research on Mirabegron Impurity 5 helps to improve the quality standard system of mirabegron, enhance drug quality, and ensure the safety and effectiveness of clinical medication.
Research Status: Currently, the research on Mirabegron Impurity 5 mainly focuses on the optimization and improvement of impurity analysis methods. By using more advanced detection technologies and instruments, the sensitivity and accuracy of detecting this impurity are improved to achieve precise determination of trace impurities. At the same time, researchers are actively exploring the source and change rules of this impurity during the synthesis and storage of mirabegron, and reducing the generation and accumulation of impurities by improving process conditions and optimizing the storage environment. In addition, the research on the potential impact of this impurity on the performance and safety of mirabegron drugs is also gradually underway, aiming to provide a more comprehensive scientific basis for the overall evaluation of mirabegron quality.