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Vildagliptin impurity M is a chemical compound that is used in the pharmaceutical industry as a reference standard for the detection and quantification of impurities in Vildagliptin, a medication used to treat type 2 diabetes. This impurity is a byproduct of the manufacturing process of Vildagliptin, and its presence can affect the efficacy and safety of the medication. Therefore, it is important to monitor and control the level of impurities in Vildagliptin.
Chemically, Vildagliptin impurity M is known as (1S,3S,5S)-2-[(2S)-2-amino-2-oxoethyl]-6,8-diaza-3-aza-tricyclo[3.3.1.1~3,7~]decane-7-carboxylic acid. It has a molecular weight of 306.37 g/mol and a molecular formula of C14H20N4O3.
To use Vildagliptin impurity M as a reference standard, it is typically synthesized and purified to a high degree of purity. This pure standard can then be used in analytical methods such as high-performance liquid chromatography (HPLC) to identify and quantify impurities in Vildagliptin samples. The use of reference standards like Vildagliptin impurity M is an important part of ensuring the quality and safety of pharmaceutical products.
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