13 research outputs found
Evaluation of interrelatedness of cities in the territorial space of Russia
The purpose of the article is to carry out the analysis of interrelatedness of cities in the territorial space of Russia. The evaluation method is based on the calculation of global and local Moran’s indexes for determination of interrelatedness of the adjacent territories by the following parameters: "population size", "population density", "average monthly salary", "shipping volume per capita". Represented as the study object were cities of the Volga Federal District of Russia with a population size over 100 thousand people in 201
Sampling in modern pharmaceutical analysis
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. Reasoned conclusions about drug quality can only be based on the results of tests conducted on representative samples, taken in accordance with certain rules and regulations. For the purpose of harmonization with foreign normative documents, systematization and updating of the requirements for sampling, specifying their conditions, general pharmacopoeia monograph «Sampling» has been developed. It regulates general rules and special aspects of drug sampling procedures for the purpose of drug quality control. The general pharmacopoeia monograph «Sampling» consolidates and classifies the materials of legislative and regulatory documents of the Russian Federation, the WHO, the EU and international pharmacopoeia monographs
Substantiation of conditions for determination of related substances in bisoprolol fumarate by HPLC
The article summarizes the results of information analysis of bisoprolol fumarate synthesis methods which differ in the number of stages and in raw materials used, and are associated with the major identified impurities A, E and G, according to the European Pharmacopoeia (Ph. Eur.). The authors performed a comparative analysis of the test procedures described in manufacturers’ quality standards, Ph. Eur. and United States Pharmacopoeia (USP) and analyzed the results of comparative experimental studies. It was shown that the implementation of the Ph. Eur. test method for related impurities according to «Bisoprolol fumarate» monograph demonstrated a high resolution between the main peak (of bisoprolol) and those of impurities A, E and G. Whereas the performance of the chromatographic system suitability testing according to the USP monograph failed to produce complete resolution between the peaks of bisoprolol and the impurities. The authors investigated the possibility of using a propranolol hydrochloride reference standard to assess the system resolution. The authors identified the conditions for determination of related substances in bisoprolol fumarate, selected chromatographic columns, proposed chromatographic system suitability criteria, including resolution between the peaks of bisoprolol and propranolol, and established limits for impurities
Determination of visible particles in parenteral dosage forms and ophthalmic dosage forms
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 and ophthalmic dosage forms», as well as a special approach to the assessment of visible particles in individual preparations according to the batch volume, package type, the amount of drug in a package, drug nature etc., requiring unusual conditions and evaluation criteria
Migration Outflow in Monotowns of Kemerovo Region Studied by Methods of Mathematical Modelling: Integrated Approach
Обоснование выбора условий определения родственных примесей методом ВЭЖХ в фармацевтической субстанции бисопролола фумарат
The article summarizes the results of information analysis of bisoprolol fumarate synthesis methods which differ in the number of stages and in raw materials used, and are associated with the major identified impurities A, E and G, according to the European Pharmacopoeia (Ph. Eur.). The authors performed a comparative analysis of the test procedures described in manufacturers’ quality standards, Ph. Eur. and United States Pharmacopoeia (USP) and analyzed the results of comparative experimental studies. It was shown that the implementation of the Ph. Eur. test method for related impurities according to «Bisoprolol fumarate» monograph demonstrated a high resolution between the main peak (of bisoprolol) and those of impurities A, E and G. Whereas the performance of the chromatographic system suitability testing according to the USP monograph failed to produce complete resolution between the peaks of bisoprolol and the impurities. The authors investigated the possibility of using a propranolol hydrochloride reference standard to assess the system resolution. The authors identified the conditions for determination of related substances in bisoprolol fumarate, selected chromatographic columns, proposed chromatographic system suitability criteria, including resolution between the peaks of bisoprolol and propranolol, and established limits for impurities.Проведены информационно-аналитические исследования возможных схем синтеза фармацевтической субстанции бисопролола фумарат, различающихся количеством стадий и исходными продуктами, в зависимости от которых основными идентифицированными примесями являются примеси A, E и G, в соответствии с монографией Европейской фармакопеи. Проведены сравнительный анализ методик, включенных в действующую нормативную документацию, монографии Европейской фармакопеи и Фармакопеи США, а также сопоставление результатов сравнительных экспериментальных исследований. Отмечено, что при воспроизведении методики определения содержания родственных примесей монографии «Бисопролола фумарат» Европейской фармакопеи наблюдалось четкое разделение основного пика (бисопролола) с пиками примесей A, E, G, в то время как при выполнении всех требований теста пригодности хроматографической системы монографии Фармакопеи США не достигалось полного разделения пиков бисопролола и примесей. Изучена возможность применения стандартного образца пропранолола гидрохлорида для оценки разрешающей способности системы. Выбраны условия определения родственных примесей в бисопролола фумарате, подобраны хроматографические колонки, предложены критерии пригодности хроматографической системы, в том числе определение разрешения между пиками бисопролола и пропранолола, установлены нормы содержания примесей
Отбор проб в современном фармацевтическом анализе
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. Reasoned conclusions about drug quality can only be based on the results of tests conducted on representative samples, taken in accordance with certain rules and regulations. For the purpose of harmonization with foreign normative documents, systematization and updating of the requirements for sampling, specifying their conditions, general pharmacopoeia monograph «Sampling» has been developed. It regulates general rules and special aspects of drug sampling procedures for the purpose of drug quality control. The general pharmacopoeia monograph «Sampling» consolidates and classifies the materials of legislative and regulatory documents of the Russian Federation, the WHO, the EU and international pharmacopoeia monographs.Процедура отбора проб является составной частью системы контроля качества лекарственных средств. Объективный научно-обоснованный отбор проб - важная операция, при которой берется только малая часть материалов, предназначенных для анализа всей серии продукции. Обоснованные выводы о качестве ЛС могут быть сделаны только на основе испытаний, проведенных на репрезентативных образцах, которые отбираются с соблюдением определенных правил и положений. С целью гармонизации с зарубежными нормативными документами, систематизации и актуализации предъявляемых требований к отбору проб, конкретизации их условий, была разработана общая фармакопейная статья «Отбор проб», которая регламентирует общие правила и особенности процедуры отбора проб лекарственных средств для контроля их качества. В общей фармакопейной статье объединены и систематизированы материалы законодательных и нормативных документов Российской Федерации, Всемирной организации здравоохранения, Европейского Союза, а также монографии зарубежных фармакопей
Определение видимых механических включений в лекарственных формах для парентерального применения и глазных лекарственных формах
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 and ophthalmic dosage forms», as well as a special approach to the assessment of visible particles in individual preparations according to the batch volume, package type, the amount of drug in a package, drug nature etc., requiring unusual conditions and evaluation criteria.Описаны подходы к выбору методик оценки содержания видимых механических включений в парентеральных и глазных лекарственных формах, принятые в общей фармакопейной статье «Видимые механические включения в лекарственных формах для парентерального применения и глазных лекарственных формах», а также особый подход к оценке видимых механических включений в отдельных лекарственных препаратах в зависимости от объема серии, вида упаковки, объема препарата в упаковке, природы лекарственного средства и др., требующих нестандартных условий и критериев оценки