{"title":"SHELF LIFE PREDICTION OF DIAGNOSTIC FLUORESCENT\u0000TULAREMIA DRY IMMUNOGLOBULINS","authors":"O. L. Startseva, S. A. Kurcheva","doi":"10.35627/2219-5238/2019-311-2-56-60","DOIUrl":"https://doi.org/10.35627/2219-5238/2019-311-2-56-60","url":null,"abstract":"We described the results of studying the stability of the main indicators of medical product quality for in\u0000vitro diagnostics - diagnostic fluorescent tularemia dry immunoglobulins RIF-Tul-StavNIPCHI,\u0000developed on the basis of Stavropol Anti-Plague Institute of Rospotrebnadzor to justify the shelf life and\u0000recommended storage conditions when used on a real scale time and accelerated research methods. At the\u0000same time, one of the main criteria for the study of stability is its study during sample storage not only\u0000in the primary packaging of an industrial output, but also after the first opening of the package, during\u0000the use period of the reconstituted preparation. On the basis of data obtained in both long-term and\u0000accelerated trials, a shelf life of three years is recommended. It was experimentally proved that during\u0000this period of time, the quality indicators of the drug remain at a level one that complies with the\u0000requirements of technical and operational documentation. In the course of application the recovered\u0000product demonstrates stability of its biological and physical-and-chemical properties within 5 days at a\u0000storage temperature of 2 to 8°С.","PeriodicalId":171066,"journal":{"name":"Здоровье населения и среда обитания - ЗНиСО","volume":"78 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124108472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}