Racecadotril EP Impurity D (Mixture of Diastereomers)

Racecadotril EP Impurity D is a mixture of Diastereomers that is used in the pharmaceutical industry as a reference standard for the identification, quantification, and characterization of impurities, degradation products, and related substances in drug formulations containing Racecadotril. Racecadotril is a potent antidiarrheal agent that acts by inhibiting the enzyme enkephalinase, which results in increased levels of endogenous opioids in the gut, leading to decreased intestinal motility and secretion. The chemical formula of Racecadotril EP Impurity D is C20H34N2O5, and its molecular weight is 390.5 g/mol. It is a white to off-white powder that is soluble in methanol, ethanol, and chloroform, and insoluble in water. The purity of Racecadotril EP Impurity D is typically greater than 98%, and it is stable under normal storage conditions. The use of Racecadotril EP Impurity D is critical in pharmaceutical analysis to ensure the safety and efficacy of drug products containing Racecadotril. It is used as a reference standard in analytical methods such as high-performance liquid chromatography (HPLC) and gas chromatography (GC) to identify and quantify impurities and related substances. These methods are used during drug development, quality control, and regulatory compliance testing. In conclusion, Racecadotril EP Impurity D is a crucial tool in the analysis and quality control of pharmaceutical formulations containing Racecadotril. Its high purity and stability make it an ideal reference standard for analytical methods used in drug development, manufacturing, and regulatory compliance.