Results 21 to 30 of about 1,535 (117)

Sampling in modern pharmaceutical analysis

Регуляторные исследования и экспертиза лекарственных средств, 2018
Sampling procedure is an integral part of the drug quality control system. Objective science-based sampling is an important operation when only a small amount of a material is taken and it is representative for the analysis of the whole product batch ...
T. N. Bokovikova, E. P. Gernikova, E. I. Sakanyan, N. D. Bunyatyan, L. I. Shishova, L. A. Stronova, S. A. Manaeva   +6 more
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Development and validation of methods of analysis of active substances in emulgel with thick extract of Tanacetum parthenium

Annals of Mechnikov's Institute, 2023
Introduction. It is known that inflammatory diseases of the muscular and skeletal systems are one of the most common pathologies affecting bones, joints, muscles, and connective tissue.
Maria Velya, Olena Ruban, Tetyana Ponomarenko, Olha Yevtifieieva   +3 more
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Analysis of Current Approaches to Monitoring the Content of Depressor Substances

Регуляторные исследования и экспертиза лекарственных средств
INTRODUCTION. Raw materials of biological origin can contaminate medicines with depressor substances, such as histamine, acetylcholine, bradykinin, serotonin, and prostaglandins.
E. O. Chechetova, T. A. Batuashvili, N. P. Neugodova   +2 more
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Equivalence assessment of quantitative tannins determination methods, used for analysis of herbal drugs

Регуляторные исследования и экспертиза лекарственных средств, 2018
The article describes results of comparative evaluation of two pharmacopoeial methods used for quantitative determination of tannins in herbal drugs: the titrimetric method of the State Pharmacopoeia of the USSR (XIth edition) that is described in the ...
N. P. Antonova, A. M. Kalinin, S. S. Prohvatilova, E. P. Shefer, T. E. Matveenkova   +4 more
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Determination of Elemental Impurities in Gelatine Capsules by Inductively Coupled Plasma Mass Spectrometry

Безопасность и риск фармакотерапии
INTRODUCTION. Gelatine capsules are an essential dosage form used for many medicinal products. Gelatine capsules are subject to quality control in accordance with the requirements of the general monograph on capsules of the State Pharmacopoeia of the ...
V. M. Shchukin, N. E. Kuz’mina, O. A. Matveeva, Yu. N. Shvetsova, E. S. Zhigilei   +4 more
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CURRENT REQUIREMENTS FOR THE QUALITY OF HERBAL MEDICINAL PRODUCTS

Регуляторные исследования и экспертиза лекарственных средств, 2018
The article provides the results of a comparative analysis of requirements laid out in the State Pharmacopoeia of the USSR, XI ed. (SPh XI) and the State Pharmacopoeia of the Russian Federation, XIII ed.
E. I. Sakanyan, E. L. Kovaleva, L. N. Frolova, V. V. Shelestova   +3 more
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Pharmacopeial Approaches to Standardization of Excipients Exemplified by Propylene Glycol and Its Derivatives

Регуляторные исследования и экспертиза лекарственных средств
INTRODUCTION. Amendments to Federal Law No. 61-FZ On Circulation of Medicines provide for additional data on excipients in general pharmacopeial monographs and pharmacopeial monographs; this necessitates the improvement of standardization requirements ...
T. B. Shemeryankina, L. I. Shishova
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Determination of visible particles in parenteral dosage forms and ophthalmic dosage forms

Регуляторные исследования и экспертиза лекарственных средств, 2018
The present article describes the approaches to the choice of methods for assessing the content of visible particles in parenteral and ophthalmic dosage forms, recognized in general pharmacopoeia monograph «Visible particles in parenteral dosage forms ...
Yu. V. Olefir, T. N. Bokovikova, L. A. Stronova, E. P. Gernikova, L. I. Mitkina, S. A. Manaeva, Yu. B. Purim, A. V. Pichugin   +7 more
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Identifying Histamine Impurity in Biological Products: Prospective Transition from in vivo to in vitro Methods

Регуляторные исследования и экспертиза лекарственных средств
INTRODUCTION. Drug impurities lowering blood pressure can cause side effects in patients. These impurities include histamine and other depressor substances.
E. A. Smiryagin, O. G. Kornilova, V. L. Bagirova   +2 more
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Microbial Quality of Dehydrated Media Used in the Sterility Testing of Immunobiological Medicinal Products

Биопрепараты: Профилактика, диагностика, лечение, 2018
Medicinal products fail sterility testing if visual observation shows the growth of microorganisms that manifests itself as turbidity, sedimentation, flocculation and other changes in the growth medium.
S. M. Sukhanova, N. E. Zakharova
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