Results 31 to 40 of about 2,318 (70)

The European Pharmacopoeia: bringing pharmaceutical standard harmonisation to Europe

Регуляторные исследования и экспертиза лекарственных средств, 2018
The article describes the history of the European Pharmacopoeia, which is a unique source of pharmacopoeial drug quality standards, not only for the European part of the continent, but for the entire pharmaceutical world.
Susanne Keitel
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Testing activity of antibiotics by agar diffusion

Регуляторные исследования и экспертиза лекарственных средств, 2018
When the quality of antibiotics and antibiotic dosage forms cannot be assessed with the help of chemical methods, one can use two variants of the agar diffusion test described in the State Pharmacopoeia XII, part 1 (General pharmacopoeial monograph 42 ...
S. I. Kuleshova
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Reference material comparisons: design of experiment and processing of measurement results

Стандартные образцы, 2017
The present article describes general principles of experimental research and processing of measurement results within the framework of one of the methods of evaluating the interchangeability of reference materials - paired comparisons of reference ...
E. V. Osintseva
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The use of certified reference materials for laboratories proficiency testing

Стандартные образцы, 2017
The notion of proficiency testing, interlaboratory comparison, proficiency testing scheme is given. The main types ofproficiency testing schemes that meet international standards is describes.
S. V. Shpakov
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Development of a plant reference material for composition of a cement raw mixture

Стандартные образцы, 2017
A plant reference material (RM) was developed, which was certified in the content of fluorine-ion (% wt) in the cement raw mixture (PRM - 1 CM).
A. N. Smagunova, I. S. Shirokolobova, V. A. Kozlov, E. N. Korzhova, O. S. Krivchenko, L. P. Shaulina, A. L. Finkelshtein   +6 more
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Global trends in the area of reference materials and the concept of the development of state service of reference materials (Part I)

Стандартные образцы, 2017
The article presents the results of research of global trends in the area of reference materials in the following directions: creation of normative documents on RMs, development of RMs, determination of RM metrological characteristics, recognition ...
E. V. Osintseva, S. V. Medvedevskikh, O. N. Kremleva, V. V. Studenok, O. V. Anfilatova, N. S. Baratova   +5 more
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The possibility of the nuclear magnetic resonance methods using for reference standards certification

Стандартные образцы, 2017
The article describes the uncertainty sources for the main stages of quantitative measurements by NMR method. It is shown that the NMR method is effective for measuring of the components molar ratio, the components relative weight portion and the ...
N. E. Kuzmina, S. V. Moiseev, V. A. Yashkir, E. V. Osintseva   +3 more
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Theoretical rationale for the choice of interferon alfa-2b substance to be certified as a reference standard for identification test by peptide mapping

Биопрепараты: Профилактика, диагностика, лечение, 2018
The article provides with the results of theoretical research on justification of the choice of methionine form of recombinant interferon alfa-2b substance to be certified as a reference standard for identification test by peptide mapping. At present non-
O. B. Ustinnikova, O. B. Runova, E. O. Goloschapova, L. V. Korsun   +3 more
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Topical issues related to reference standards in the sphere of circulation of biological products

Биопрепараты: Профилактика, диагностика, лечение, 2018
Pharmacopoeial analytical methods involving reference standards (RS) are used for manufacture and quality control of medicinal products, including biologicals, these RS should now to be called pharmacopoeal.
R. A. Volkova, O. V. Fadeikina, V. I. Klimov, E. I. Sakanyan, Yu. V. Olefir, V. A. Merkulov, A. A. Movsesyants, V. P. Bondarev, I. V. Borisevich, D. V. Shvedov   +9 more
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GOST 8.315 "GSI. Reference materials of composition and properties of substances and materials. Basic concepts": basic principles of revision

Стандартные образцы, 2017
A key point of the revision of GOST 8.315"GSI. Reference materials of composition and properties of substances and materials. Basic concepts" is harmonization with the documents of International Organization for Standardization (ISO) and International ...
E. V. Osintseva
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