ABOUT GEOLOGICAL IMPORTANCE OF DISCOVERED BY YOUNG GEOLOGISTS OF NIZHEGORODSKIY GEOLOGICAL CENTER “SEMIPRECIOUS” UNIQUE TECTONICALLY DISTURBED STEEP CLIFF NEAR VILLAGE BEZVODNOE OF KSTOVSKIY DISTRICT (from the series “Wonderful geographical places of Nizhny Novgorod Volga region”)

In the article considered some aspects of forming of Volga’s and Oka’s valley, scarp slope of right fundamental slope of its valley - Mstersko-Kozmodemjanskaja ridge, tracing the weakened zone in crystalline basement (Vladimiro-Kazanskaja boundary). Presented the description of steep cliff of monocline falling rock layers of lowermost horizon of urzhumskiy tier, crashed into blocks by many faults, which proves tectonic determination of the most Northern structure of Privolzhskaja upland - Mstersko-Kozmodemjanskaja ridge

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

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

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

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