Abstract

The study of antibiotics as a potential drug, in addition in order to develop effective methods for assessing quality in preclinical stage includes the establishment of stability and expiry date. This study regulatory requirement is necessary to establish the time during which the substance remains unchanged physical, chemical, biological properties, i.e. suitable to all requirements of regulatory documentation. Justification of the established expiry date of the substance is included in the section of the registration dossier on the methods of quality assessment. The purpose of this study is to establish the expectancy duration and stability of the antibiotics of the cephalosparin group of a number produced by #x201C;Jurabek Laboratories#x201D; JV LLC.