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Regulations of Genotoxic Impurities in Pharmaceuticals.
В наличии
Местонахождение: Алматы | Состояние экземпляра: новый |
Бумажная
версия
версия
Автор: Mukesh Maithani,Vikas Gupta and Parveen Bansal
ISBN: 9786139926947
Год издания: 2018
Формат книги: 60×90/16 (145×215 мм)
Количество страниц: 68
Издательство: LAP LAMBERT Academic Publishing
Цена: 23493 тг
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Аннотация: The impurities in pharmaceuticals are superfluous chemicals that remain with the active pharmaceutical ingredients (APIs) or develop during formulation or upon aging of both pharmaceutical ingredients and formulation. The presence of these superfluous chemicals even in small amount may manipulate the safety and efficacy of pharmaceutical product. Some of these impurities also known as genotoxic impurities (GIs) could be mutagens or carcinogens and cause adverse effects on the human body even in trace amount. Starting materials, reagents, intermediates, by products, and degradation products are often found as impurities in active pharmaceutical ingredients. There are several regulatory guidelines and position papers focused on controlling the amount of impurities within specified limits. The present compilation gives an account of updated information about GIs and reviews the regulatory aspects for GIs in active pharmaceutical ingredients/drug formulations. A detailed discussion about control strategies in the context of GIs is also described precisely.
Ключевые слова: genotoxic impurities, Pharmaceutical