Erythromycin EP Impurity M

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E-mail: anna@molcoo.com

• Product Information

• Product Number: E016014

• English Name: Erythromycin EP Impurity M

• English Alias: (3R,4S,5S,6R,7R,9R,11R,12S,13R,14R)-6-(((2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-14-ethyl-7,12-dihydroxy-4-(((2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl)oxy)-3-(hydroxymethyl)-5,7,9,11,13-pentamethyloxacyclotetradecane-2,10-dione

• CAS Number: 616234-56-1

• Molecular Formula: C37H67NO13

• Molecular Weight: 733.93

• Advantages: As the European Pharmacopoeia (EP) impurity M standard of erythromycin, it has a well-defined chemical structure and has undergone strict identification, with high purity and strong stability, which can maintain stable properties under different environmental conditions and storage periods. Its precise quality control system ensures that it can serve as a reliable benchmark in the quality inspection of erythromycin and its preparations, guaranteeing the accuracy and repeatability of impurity detection results, and meeting the high standards required for drug research and development, production, and quality supervision.

• Applications: It is mainly used in the quality research, impurity analysis, and quality control of erythromycin 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 erythromycin, it helps to study the source and formation mechanism of impurities, and optimize the synthesis process to reduce impurity generation. In the production process, it is used to monitor the content of impurity M 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 erythromycin drugs during storage and transportation, providing data support for drug stability research and helping to improve the overall quality of erythromycin drugs.

• Background Description: Erythromycin is a widely used macrolide antibiotic that plays an important role in clinical anti-infective treatment. In the process of erythromycin 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 erythromycin are required. As one of the key impurities of erythromycin, in-depth research on Erythromycin EP Impurity M helps to improve the quality standard system of erythromycin, enhance drug quality, and ensure the safety and effectiveness of clinical medication.

• Research Status: Currently, the research on Erythromycin EP Impurity M is continuously advancing. In terms of impurity detection technology, more sensitive, rapid, and accurate detection methods are constantly being explored 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 erythromycin are analyzed in depth by combining chemical reaction principles with the actual production process, 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 erythromycin drugs is also gradually underway. Through in vitro and in vivo experiments, its potential risks are evaluated, providing a more scientific and sufficient basis for overall quality control.

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NOTE！

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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