STUDY OF MICROBIOLOGICAL PURITY OF TABLETS "URONEFRON"
The article covers a development and validation test of microbiological purity determination method for tablets «Uronefron» produced on the basis of herbal raw materials. The method is developed in accordance with the European Pharmacopoeia requirements to non-sterile finished medicinal products in forms of tablets. The factors influenced on the microbiological purity of non-sterile medicinal product are analyzed. The set of microbiological studies is performed in order to develop the test procedure of microbiological purity for tablets «Uronefron». Validation test of test method related to the certain type of microorganisms is carried out. It is established with performed studies that tablets of «Uronefron» related to the parameter of «Microbiological purity» meet with the European Pharmacopoeia requirements to medicines of category 2. Standardization of microbiological purity is determined and included to the draft of analytical procedure for tablets «Uronefron».