Clarithromycin EP impurity C

Clarithromycin EP impurity C, also known as N-desmethylclarithromycin, is an impurity of the macrolide antibiotic Clarithromycin. Clarithromycin is commonly used to treat respiratory tract infections, skin infections, and other bacterial infections. However, impurities like N-desmethylclarithromycin can affect the purity and efficacy of the final product. N-desmethylclarithromycin is formed during the metabolism of Clarithromycin in the liver. It is a major metabolite of Clarithromycin and is excreted in the urine. N-desmethylclarithromycin has been found to exhibit some antibacterial activity but is significantly less active than Clarithromycin. The chemical structure of N-desmethylclarithromycin is similar to that of Clarithromycin, with the exception of the absence of a methyl group on the nitrogen atom. It has a molecular weight of 697.84 g/mol and a melting point of 173-178°C. As an impurity, N-desmethylclarithromycin should be controlled and monitored during the production of Clarithromycin to ensure the purity and quality of the final product. Analytical methods such as high-performance liquid chromatography (HPLC) and gas chromatography-mass spectrometry (GC-MS) can be used to detect and quantify N-desmethylclarithromycin in Clarithromycin samples.