Abstract
Thestudy 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 “Jurabek Laboratories” JV LLC.
Highlights
IntroductionStability (sustainability) is a factor in the quality of medicines. The criterion for the stability of a medicinal substance is the preservation of its quality, i.e. appearance, solubility, authenticity, good quality and quantitative content
Stability is a factor in the quality of medicines
The criterion for the stability of a medicinal substance is the preservation of its quality, i.e. appearance, solubility, authenticity, good quality and quantitative content
Summary
Stability (sustainability) is a factor in the quality of medicines. The criterion for the stability of a medicinal substance is the preservation of its quality, i.e. appearance, solubility, authenticity, good quality and quantitative content. Chemical processes occurring during storage of drugs are investigated and methods are created to inhibit these processes The solution of these problems is possible only on the basis of the development of methods for analyzing medicinal substances in the presence of their decomposition products. The results of these studies are taken into account when developing the technology of obtaining drugs and ND. In determining the expiration dates, they were guided by the requirements of the Global Fund XI and the Interim Instruction I-42-2-82 According to these documents, the establishment of stability is possible using the following methods: − Test under long-term storage conditions; − Testing under conditions of “accelerated aging”. Experimental substance series: tэ is the temperature of experimental storage
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