Аннотация
Переведена и печатается с согласия авторов и редакции «Journal of Chemotherapy» 2003; 15:357-68. Проведено сравнение фармацевтического качества Роцефина® с 34 генерическими препаратами цефтриаксона. В 18 случаях выявлено нарушение стандартов качества, установленных Европейской и Американской фармакопеями, включая нарушение стерильности (4 препарата) и наличие примесей (5 препаратов). Все 34 тестированных генерических препарата цефтриаксона не соответствовали требованиям спецификации для Роцефина®, предъявляемым компанией Roche. Зарегистрировано 100 отклонений от фармацевтических стандартов компании Roche, наиболее частыми из которых, выявленными при тестировании генериков цефтриаксона, были нарушение требований к прозрачности раствора (30 препаратов) и наличие примеси тиотриазина (33 препарата).
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