Frist für Nitrosamin-Verunreinigungen: Sind Ihre Produkte konform? - Adare Pharma Lösungen

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Die FDA hat kürzlich ihre Leitlinien zur Nitrosamin-Kontamination veröffentlicht und Fristen für die Aktualisierung der Risikobewertung und die vollständige Einhaltung der Vorschriften festgelegt. Dieses Problem betrifft einen nicht geringen Teil der Branche: Etwa 30 % der zugelassenen pharmazeutischen Wirkstoffe (APIs) sind anfällig für die Bildung von Nitrosaminen. In diesem Artikel gehen wir ausführlich auf die Leitlinien ein, betrachten verschiedene Ansätze zur Verringerung von Verunreinigungen und zeigen, wie das einzigartige Nitrosamin-Minderungsverfahren von Adare dazu beitragen kann, dass Produkte die Anforderungen erfüllen.

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