{"id":2952,"date":"2025-06-27T17:40:41","date_gmt":"2025-06-27T17:40:41","guid":{"rendered":"https:\/\/nano-test.de\/?p=2952"},"modified":"2025-07-01T10:19:58","modified_gmt":"2025-07-01T10:19:58","slug":"nitrosamin-analyse-in-arzneimitteln-ep-usp-bp-und-jp","status":"publish","type":"post","link":"https:\/\/nano-test.de\/en\/2025\/06\/27\/nitrosamin-analyse-in-arzneimitteln-ep-usp-bp-und-jp\/","title":{"rendered":"Nitrosamine Analysis in Drugs: EP, USP, BP and JP"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"2952\" class=\"elementor elementor-2952\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-09fc1e8 ts-col-stretched-none ts-bg-color-over-image elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"09fc1e8\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-e31301b ts-bg-color-over-image\" data-id=\"e31301b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e3a5c65 elementor-widget elementor-widget-text-editor\" data-id=\"e3a5c65\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"color: #000000;\">Eines der am meisten diskutierten Themen in der Arzneimittelbranche in den letzten Jahren war die <a href=\"https:\/\/nano-test.de\/en\/research\/nitrosamin-analyse\/\"><b>Nitrosaminverunreinigung<\/b><\/a>. Nitrosamine sind Verbindungen mit potenziell krebserregenden Eigenschaften, deren Nachweis in einigen Arzneimitteln weltweit zu gro\u00df angelegten R\u00fcckrufaktionen gef\u00fchrt hat. Aus diesem Grund muss die <b>Nitrosaminanalyse in Arzneimitteln<\/b> gem\u00e4\u00df den internationalen Pharmakop\u00f6en (EP, USP, BP, JP) sorgf\u00e4ltig durchgef\u00fchrt werden.<\/span><\/p><h3><span style=\"color: #000000;\"><strong>What are nitrosamines?<\/strong><\/span><\/h3><p><span style=\"color: #000000;\">Nitrosamines are chemical compounds that are usually formed by the reaction of secondary amines with nitrites. They may unintentionally arise in industrial processes, in food and in the manufacture of drugs. Since most of these substances can have carcinogenic effects on human health with prolonged exposure, they are strictly controlled by international authorities.<\/span><\/p><blockquote><h3><span style=\"color: #000000;\"><strong>Sources of nitrosamines in medicines<\/strong><\/span><\/h3><p><span style=\"color: #000000;\">Nitrosamines can occur at different stages of the drug manufacturing process:<\/span><\/p><ul><li><span style=\"color: #000000;\">Contamination of raw materials<\/span><\/li><li><span style=\"color: #000000;\">Reagents or solvents used in production<\/span><\/li><li><span style=\"color: #000000;\">Formation of by-products<\/span><\/li><li><span style=\"color: #000000;\">Transfer from packaging materials<\/span><\/li><li><span style=\"color: #000000;\">Decomposition during storage and shelf life<\/span><\/li><\/ul><p><span style=\"color: #000000;\">Diese Risiken sind insbesondere bei Produkten wie <b>Antihypertensiva der Sartan-Gruppe<\/b>, <b>Metformin<\/b> and <b>Ranitidin<\/b> aufgetreten.<\/span><\/p><\/blockquote><h3><span style=\"color: #000000;\"><strong>International Standards: EP, USP, BP, JP approaches<\/strong><\/span><\/h3><p><span style=\"color: #000000;\">In order to prevent nitrosamine contamination worldwide, the pharmaceutical industry is oriented towards four basic sources:<\/span><\/p><ul><li><span style=\"color: #000000;\"><a href=\"https:\/\/pheur.edqm.eu\/home\"><b>EP (Europ\u00e4isches Arzneibuch)<\/b><\/a>: Legt Nitrosamin-Grenzwerte und obligatorische Validierungsmethoden fest.<\/span><\/li><li><span style=\"color: #000000;\"><a href=\"https:\/\/www.usp.org\/\"><b>USP (US-Arzneibuch)<\/b><\/a>: Stellt Leitlinien f\u00fcr Nitrosamin-Analysemethoden und Grenzwerttests bereit.<\/span><\/li><li><span style=\"color: #000000;\"><b>BP (Britisches Arzneibuch)<\/b>: Enth\u00e4lt parallel zum Europ\u00e4ischen Arzneibuch Qualit\u00e4tskontrollanforderungen.<\/span><\/li><li><span style=\"color: #000000;\"><b>JP (Japanisches Arzneibuch)<\/b>: Legt Qualit\u00e4ts- und Sicherheitsstandards fest, die eine Nitrosamin-Analyse vorschreiben.<\/span><\/li><\/ul><p><span style=\"color: #000000;\">The aim of all these standards is to set limits that do not endanger human health and apply reliable methods of analysis.<\/span><\/p><h3><span style=\"color: #000000;\"><strong>Why is nitrosamine analysis important?<\/strong><\/span><\/h3><ul><li><span style=\"color: #000000;\">Avoidance of cancer risks<\/span><\/li><li><span style=\"color: #000000;\">Conformity of approved medicines with international regulations<\/span><\/li><li><span style=\"color: #000000;\">Minimizing the recall risk<\/span><\/li><li><span style=\"color: #000000;\">Ensuring patient safety<\/span><\/li><li><span style=\"color: #000000;\">Manufacturer's reputation and compliance with legal regulations<\/span><\/li><\/ul><p><span style=\"color: #000000;\">Nitrosamin analysis is not only a prescribed legal process, but also an important step towards quality assurance in the interest of human health.<\/span><\/p><h3><span style=\"color: #000000;\"><strong>Effective drug safety analysis<\/strong><\/span><\/h3><p><span style=\"color: #000000;\">Arzneimittelhersteller und -importeure m\u00fcssen in jeder Phase ihrer Produkte eine <b>Nitrosamin-Risikobewertung<\/b> durchf\u00fchren und diese Risiken durch Analysen gem\u00e4\u00df internationalen Standards minimieren. Sorgf\u00e4ltige Nitrosamin-Tests gem\u00e4\u00df den Arzneib\u00fcchern EP, USP, BP und JP gew\u00e4hrleisten sowohl die Produktqualit\u00e4t als auch die \u00f6ffentliche Gesundheit.<\/span><\/p><p><span style=\"color: #000000;\">If you would like to have nitrosamine analyzes carried out for your medicines or would like more information, you can contact competent and accredited laboratories.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Eines der am meisten diskutierten Themen in der Arzneimittelbranche in den letzten Jahren war die Nitrosaminverunreinigung. Nitrosamine sind Verbindungen mit potenziell krebserregenden Eigenschaften, deren Nachweis in einigen Arzneimitteln weltweit zu gro\u00df angelegten R\u00fcckrufaktionen gef\u00fchrt hat. Aus diesem Grund muss die Nitrosaminanalyse in Arzneimitteln gem\u00e4\u00df den internationalen Pharmakop\u00f6en (EP, USP, BP, JP) sorgf\u00e4ltig durchgef\u00fchrt werden. Was \u2026 <a href=\"https:\/\/nano-test.de\/en\/2025\/06\/27\/nitrosamin-analyse-in-arzneimitteln-ep-usp-bp-und-jp\/\" class=\"more-link\" title=\"Continue reading &amp;lt;span class=\" screen-reader-text>Nitrosamin-Analyse in Arzneimitteln: EP, USP, BP und JP\u201c&gt;Continue reading <span class=\"screen-reader-text\">Nitrosamine Analysis in Drugs: EP, USP, BP and JP<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":2953,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[],"class_list":["post-2952","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Nitrosamin-Analyse in Arzneimitteln: EP, USP, BP und JP |Nano-Test\u00ae<\/title>\n<meta name=\"description\" content=\"Wir analysieren 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