Results 41 to 50 of about 447 (130)
Ways to Improve Quality Control of Culture Medium Used for Mycoplasma Detection
Биопрепараты: Профилактика, диагностика, лечение, 2019 An urgent safety concern associated with biological products is contamination with mycoplasmas, which may originate from donor tissues and organs, virus harvests, culture medium components, trypsin, animal blood serum, as well as be transmitted by ...
S. M. Sukhanova +2 more
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Регуляторные исследования и экспертиза лекарственных средств, 2019 Algae tend to accumulate elemental toxic substances in high concentrations. Algae are widely used in the food and pharmaceutical industries, and this dictates the need to establish limits for the content of toxic substances that they may contain. The aim
V. M. Shchukin +3 more
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Water for injections: Global trends in pharmacopoeial quality assessment and Russian expert practice
Биопрепараты: Профилактика, диагностика, лечениеINTRODUCTION. High quality standards for sterilised water for injections arise from the need to guarantee the safety and effectiveness of injectable medicines, especially biologicals, since the presence of impurities in the solvent (mainly microbial ...
S. M. Sukhanova +2 more
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Application of HPLC for Evaluation and Standardisation of Hawthorn Flower Herbal Substance
Регуляторные исследования и экспертиза лекарственных средств, 2019 The process of harmonisation of Russian and foreign approaches and requirements in the field of medicines quality assurance calls for revision of quality control procedures included in various regulations and guidelines.
N. P. Antonova +5 more
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Биопрепараты: Профилактика, диагностика, лечение, 2018 The article is devoted to a comparative analysis of requirements to the heterologous serum products stipulated in the world leading Pharmacopoeias: the US Pharmacopoeia, the European Pharmacopoeia, the British Pharmacopoeia, the Japanese Pharmacopoeia ...
O. V. Perelygina, E. I. Komarovskaya
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Patent information retrieval in the preparation of pharmacopeia articles on drugs projects
Регуляторные исследования и экспертиза лекарственных средств, 2018 The article covers the issues of patent information retrieval technologies for the elaboration of draft pharmacopoeia monographs on immunobiologicals. It describes the opportunities of automated search in the databases of the Russian Federal Agency for ...
A. A. Elapov +2 more
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Current approaches to the control of process-related impurities in antibiotics
Регуляторные исследования и экспертиза лекарственных средствINTRODUCTION. Antibiotic active substances have a distinct class of organic impurities other than related substances or organic solvents, namely, process-related impurities, such as N,N-dimethylaniline and 2-ethylhexanoic acid and its derivatives.
E. L. Kovaleva +2 more
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TABLETS. REGULATORY REQUIREMENTS OF THE STATE PHARMACOPOEIA XIII EDITION
Разработка и регистрация лекарственных средств, 2019 Comparative analysis of pharmacopoeial requirements for dosage forms tablets has been made due to the introduction of the State Pharmacopoeia of the Russian Federation XIII edition. An overview of changed requirements can be useful for revision (reissue)
N. V. Isaeva +2 more
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Current Requirements for Information Content and Graphic Design of a Medicinal Product Package
Регуляторные исследования и экспертиза лекарственных средств, 2019 Labeling is an important source of information about a medicinal product. The completeness and accuracy of labeling ensures correct identification, as well as safe and efficacious use of the product.
L. I. Mit'kina, Anastasiya K. Ericheva
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Development of a Quantitative Determination Method for Aluminum Ions in Adsorbed Drugs Using Atomic Absorption Spectrometry with Electrothermal Atomization. [PDF]
Pharm Chem J, 2022 Makarishcheva DD +3 more
europepmc +1 more source