Innovative Synthesis Isolation and characterization of Some Impurities of Macrolide Antibiotic

Abstract

Impurities in Drug substances and Drug products are the big challenges for the Industry to address the quality of product. It has been a tough task for the companies to meet present stringent regulatory norms. There are so many strategies that the companies are following to fulfill the regulatory requirement and to meet the compliance. If the product is in pharmacopeia either in USP/EP/BP then one must follow the same criteria as defined in the respective monographs. If the product is either new or non pharmacoepial then companies has to meet the quality of product as per the ICH guidelines or equivalent to Innovator product. No company can sell their product in any regulated market without meeting the quality criteria. These quality parameters as described in their individual monograms mentioned in respective pharmacoepia. Impurities in pharmaceuticals are unwanted chemicals that remain with the active pharmaceutical ingredient either in form of unreacted chemicals, by-products, degradation product, catalyst, reagents or solvents used in the process. These unwanted products even in small amounts may influence efficacy and safety of pharmaceutical products. Even low level of these impurities may cause serious toxic effect to human physiological system. Clarithromycin is a 14- membered macrolide antibiotic used to treat Pharyngitis, tonsillitis, acute maxillary, Sinusitis, acute bacterial exacerbation of chronic bronchitis, pneumonia, especially typical pneumonia associated with Chlamydia and, in HIV and AIDS patient to prevent and to treat disseminated Mycobacterium avium complex (MAC). In addition, it is sometimes used to treat Legionellosis.Clarithromycin exhibits excellent antibacterial activity against gram-positive bacteria, some gram-negative bacteria, anaerobic bacteria, mycloplasmas and chlamydias. It is useful in the therapy for infections of the upper and lower respiratory tract in human and children.