Clarithromycin EP impurity P

Clarithromycin EP Impurity P is a chemical compound that is commonly used in the pharmaceutical industry as a reference standard for the identification, quantification, and characterization of impurities present in Clarithromycin drug substances and products. It is a highly pure and stable compound that is characterized by its white to off-white crystalline powder form and its high solubility in water. In terms of its chemical properties, Clarithromycin EP Impurity P is a derivative of Clarithromycin, which is a macrolide antibiotic used to treat a variety of bacterial infections. The compound has a molecular weight of 748.98 g/mol and a molecular formula of C38H69NO13. It is composed of a complex structure that includes a lactone ring, a nitrogen-containing macrolactam ring, and a hydroxylated sugar moiety. The usage of Clarithromycin EP Impurity P is critical in the pharmaceutical industry as it helps in ensuring the quality and safety of Clarithromycin drug substances and products. The compound is used as a standard reference material for the development and validation of analytical methods that are used to detect and quantify impurities in Clarithromycin products. It also helps in identifying any degradation products that may arise during the manufacturing process or storage of Clarithromycin products. In conclusion, Clarithromycin EP Impurity P is an essential chemical compound used in the pharmaceutical industry for the identification and quantification of impurities in Clarithromycin drug substances and products. Its high purity and stability make it a reliable reference standard for the development and validation of analytical methods used in the quality control of Clarithromycin products.