{"id":2232,"date":"2025-06-23T14:09:37","date_gmt":"2025-06-23T14:09:37","guid":{"rendered":"https:\/\/nano-test.de\/?p=2232"},"modified":"2025-07-01T10:22:41","modified_gmt":"2025-07-01T10:22:41","slug":"physikalisch-chemische-prufungen-in-pharmazeutischen","status":"publish","type":"post","link":"https:\/\/nano-test.de\/it\/2025\/06\/23\/physikalisch-chemische-prufungen-in-pharmazeutischen\/","title":{"rendered":"Test chimico-fisici nei prodotti farmaceutici"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"2232\" class=\"elementor elementor-2232\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5a6f2af3 ts-col-stretched-none ts-bg-color-over-image elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5a6f2af3\" 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-6f7ba71a ts-bg-color-over-image\" data-id=\"6f7ba71a\" 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-6ac46c87 elementor-widget elementor-widget-text-editor\" data-id=\"6ac46c87\" 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<h2><span style=\"color: #000000;\">Test fisico-chimici per prodotti farmaceutici nell'ambito del GLP<\/span><\/h2><p><span style=\"color: #000000;\">Angesichts der Auswirkungen pharmazeutischer Produkte auf die menschliche Gesundheit ist eine sorgf\u00e4ltige Pr\u00fcfung dieser Produkte hinsichtlich ihrer Qualit\u00e4t und Sicherheit unerl\u00e4sslich. Physikalisch-chemische Tests, die im Rahmen der Guten Laborpraxis (<a href=\"https:\/\/nano-test.de\/it\/service\/gute-laborpraxis-glp\/\">GLP<\/a>) durchgef\u00fchrt werden, best\u00e4tigen anhand wissenschaftlicher Daten die \u00dcbereinstimmung pharmazeutischer Produkte mit wichtigen Kriterien wie Identit\u00e4t, Reinheit, Feuchtigkeitsgehalt und mikrobiologischer Reinheit. In unserem GLP-akkreditierten Labor bieten wir unseren Kunden zuverl\u00e4ssige Analysedienstleistungen mit Tests, die gem\u00e4\u00df den Monografien der Ph. Eur. (Europ\u00e4isches Arzneibuch) und USP (Amerikanisches Arzneibuch) durchgef\u00fchrt werden.<\/span><\/p><h2><span style=\"color: #000000;\">Il ruolo dei test fisico-chimici nell'ambito del GLP<\/span><\/h2><p><span style=\"color: #000000;\">Gli standard GLP regolano la pianificazione, l'implementazione, la tracciabilit\u00e0 e la segnalazione dei test e quindi aumentano l'affidabilit\u00e0 dei risultati. In questo modo, i produttori possono effettuare il controllo di qualit\u00e0 dei propri prodotti farmaceutici secondo gli standard internazionali e garantire il rispetto delle normative.<\/span><\/p><h3><span style=\"color: #000000;\">I test fisico-chimici pi\u00f9 importanti che eseguiamo nell'ambito del GLP<\/span><\/h3><h4><span style=\"color: #000000;\">\u2022 Test di identificazione<\/span><\/h4><p><span style=\"color: #000000;\">Um zu best\u00e4tigen, dass es sich bei einem <a style=\"color: #000000;\" href=\"https:\/\/nano-test.de\/it\/research\/pharmazeutische-produktprufungen\/\">Arzneimittelwirkstoff<\/a> oder einer Formulierung um den richtigen Stoff handelt, werden verschiedene physikalische und chemische Methoden angewendet. Dazu geh\u00f6ren:<\/span><\/p><ul><li><span style=\"color: #000000;\">Metodi spettroscopici (IR, UV, NMR)<\/span><\/li><li><span style=\"color: #000000;\">Metodi cromatografici (HPLC, GC)<\/span><\/li><li><span style=\"color: #000000;\">Prove di reazione chimica.<\/span><\/li><\/ul><p><span style=\"color: #000000;\">Questi test garantiscono che il prodotto abbia l'identit\u00e0 indicata sull'etichetta. (ph. EUR., USP)<\/span><\/p><h4><span style=\"color: #000000;\">\u2022 Test di purezza<\/span><\/h4><p><span style=\"color: #000000;\">Questi test vengono eseguiti per rilevare la potenziale contaminazione del principio attivo o della formulazione. Questi test determinano sostanze indesiderate come<\/span><\/p><ul><li><span style=\"color: #000000;\">Residui di solvente<\/span><\/li><li><span style=\"color: #000000;\">Residui di reazione<\/span><\/li><li><span style=\"color: #000000;\">Prodotti di decomposizione<\/span><\/li><\/ul><p><span style=\"color: #000000;\">Vengono eseguiti con controlli limite o metodi di analisi quantitativa. (ph. EUR., USP)<\/span><\/p><h4><span style=\"color: #000000;\">\u2022 Determinazione del contenuto di acqua<\/span><\/h4><p><span style=\"color: #000000;\">Il contenuto di umidit\u00e0 ha un'influenza diretta sulla durata e la stabilit\u00e0 di molti prodotti farmaceutici.<\/span><\/p><ul><li><span style=\"color: #000000;\">Die g\u00e4ngigste Methode, die <b>Titolazione di Karl Fischer<\/b>, wird verwendet, um den Wassergehalt im Produkt genau zu bestimmen. (Ph. Eur., USP)<\/span><\/li><\/ul><h4><span style=\"color: #000000;\">\u2022 Test di sterilit\u00e0<\/span><\/h4><p><span style=\"color: #000000;\">Bei <a href=\"https:\/\/nano-test.de\/it\/service\/pharma\/\">pharmazeutischen<\/a> Produkten, die steril sein m\u00fcssen (Injektionsl\u00f6sungen, Augentropfen usw.), wird festgestellt, ob lebende Mikroorganismen vorhanden sind.<\/span><\/p><ul><li><span style=\"color: #000000;\"><a href=\"https:\/\/nano-test.de\/it\/research\/sterilitatstest\/\">Sterilit\u00e4tstests<\/a> werden unter aseptischen Bedingungen durchgef\u00fchrt.<\/span><\/li><li><span style=\"color: #000000;\">Vengono effettuati in conformit\u00e0 con ISO 11737-2 e i riferimenti alla farmacopea. (ph. EUR., USP)<\/span><\/li><\/ul><h4><span style=\"color: #000000;\">\u2022 Test batterico dell'endotossina<\/span><\/h4><p><span style=\"color: #000000;\">Questo test \u00e8 di fondamentale importanza per i prodotti parenterali e alcuni dispositivi medici:<\/span><\/p><ul><li><span style=\"color: #000000;\">Rileva endotossine batteriche pirogeniche.<\/span><\/li><li><span style=\"color: #000000;\">Viene eseguito utilizzando il metodo del lisato amebocitario del limulus. Questo test assicura che i prodotti non contengano sostanze che possono causare febbre dopo l'iniezione. (ph. EUR., USP)<\/span><\/li><\/ul>\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>Physikalisch-chemische Tests f\u00fcr pharmazeutische Produkte im Rahmen der GLP Angesichts der Auswirkungen pharmazeutischer Produkte auf die menschliche Gesundheit ist eine sorgf\u00e4ltige Pr\u00fcfung dieser Produkte hinsichtlich ihrer Qualit\u00e4t und Sicherheit unerl\u00e4sslich. Physikalisch-chemische Tests, die im Rahmen der Guten Laborpraxis (GLP) durchgef\u00fchrt werden, best\u00e4tigen anhand wissenschaftlicher Daten die \u00dcbereinstimmung pharmazeutischer Produkte mit wichtigen Kriterien wie Identit\u00e4t, Reinheit, \u2026 <a href=\"https:\/\/nano-test.de\/it\/2025\/06\/23\/physikalisch-chemische-prufungen-in-pharmazeutischen\/\" class=\"more-link\" title=\"Continue reading &lt;span class=\" screen-reader-text>Physikalisch-chemische Pr\u00fcfungen in pharmazeutischen\u201c&gt;Continue reading <span class=\"screen-reader-text\">Test chimico-fisici nei prodotti farmaceutici<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":2234,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-2232","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-glp-blog"],"yoast_head":"<!-- This site is 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