Hubei Moxin Biotechnology Co., Ltd
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Business Type:Lab/Research institutions
Tel: +86-173-20513646
Mobile: 17320513646
Tel: +86-173-20513646
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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
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Advantages: As the European Pharmacopoeia (EP) impurity B standard of carbamazepine, it has a clear chemical structure, and its purity has been strictly verified. It has good batch stability and strong repeatability. In the drug quality control process, it can provide accurate and reliable reference for the impurity detection of carbamazepine and its preparations, ensuring the accuracy and consistency of detection results, and helping pharmaceutical companies and research institutions effectively control drug quality to meet regulatory requirements.
Carbamazepine EP Impurity B
Product Information
Product Number: C139001
English Name: Carbamazepine EP Impurity B
English Alias: 9-methylacridine
CAS Number: 611-64-3
Molecular Formula: C14H11N
Molecular Weight: 193.24
Advantages: As the European Pharmacopoeia (EP) impurity B standard of carbamazepine, it has a clear chemical structure, and its purity has been strictly verified. It has good batch stability and strong repeatability. In the drug quality control process, it can provide accurate and reliable reference for the impurity detection of carbamazepine and its preparations, ensuring the accuracy and consistency of detection results, and helping pharmaceutical companies and research institutions effectively control drug quality to meet regulatory requirements.
Applications: It is mainly applied to the quality research and control of carbamazepine 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). During the research and development of carbamazepine drugs, 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 B in products in real time, ensuring that drug quality meets the European Pharmacopoeia and other relevant quality standards. It can also be used to evaluate the changes of impurities in carbamazepine drugs during storage and transportation, providing data support for drug stability research.
Background Description: Carbamazepine is a drug widely used in clinical practice for the treatment of epilepsy and neuropathic pain. In the process of its production and research and development, 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 various impurities in carbamazepine are required. As one of the key impurities of carbamazepine, in-depth research on Carbamazepine EP Impurity B helps to improve the quality standard system of carbamazepine, enhance drug quality, and promote the healthy development of the pharmaceutical industry.
Research Status: Currently, the research on Carbamazepine EP Impurity B continues to deepen. In terms of analysis and detection, more sensitive and accurate detection technologies are constantly being explored, such as ultra-high-performance liquid chromatography (UHPLC) and high-resolution mass spectrometry, to achieve precise determination of trace impurities. In the study of impurity generation mechanisms, the root causes of its generation during the synthesis and storage of carbamazepine are explored in depth by combining reaction chemistry theories and experimental data, so as to optimize process conditions in a targeted manner. At the same time, the research on the impact of this impurity on the performance and safety of carbamazepine drugs is also gradually underway, providing a more comprehensive scientific basis for overall quality control