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Information × Registration Number 0304U001818, 0103U006269 , R & D reports Title Comparative assesmeut of estimationmethods on microbiologicae purity for nonsteroidal drugs popup.stage_title Порівняльна оцінка методів визначення мікробіологічної чистоти для нестерильних лікарських засобів Head Chumak Victor, Registration Date 09-04-2004 Organization Central laboratory for guality control of medicines popup.description2 While testing microbiological purity of medicinal products, direct inoculation and membrane filtration methods included in State Pharmacopoeia of Ukraine, Edition 1 are used. Along with the above mentioned methods in national part of Pharmacopoeia for medicinal products insoluble in water and forming suspensions (tablets, powders, etc.) using supernatant fluid or prefilters is provided by method of membrane filtration. In practice, method of membrane filtration using supernatant fluid and prefilters caused a problem of objective appraisal of degree of microbiological impurity of medicinal products. To find solution of this problem experimental investigations were conducted with certain medicinal products (tablets, capsules, powders) using method of membrane filtration with prefilters and supernatant fluid in two independent laboratories in the presence of independent expert. The results of investigation showed that uncertain results are possible, therefore objective appraisal of degree of microbiological impurity of medicinal products couldn't be given. On the basis of conducted research work the decision was taken to exclude from national part of State Pharmacopoeia of Ukraine, Edition 1 using prefilters or supernatant fluid in the method of membrane filtration for microbiological control of medicinal products, insoluble in water or forming suspensions (tablets, powders, etc.). Product Description popup.authors popup.nrat_date 2020-04-02 Close