🇪🇺 OMCL Network published NDSRIs Analytical Methods

[Naiffer_Host]

The network of official medicines control laboratories (OMCL) published a series of analytical method for determination of nitrosamine drug substance-related impurities (NDSRIs)

The German OMCL at the Landesamt für Gesundheit und Lebensmittelsicherheit (LGL) in Bavaria established the following methods:

• GC-MS/MS method for the determination of NTTP in sitagliptin/sitagliptin/metformin tablets
• LC-MS/MS method for the determination of N-nitroso-ramipril in ramipril tablets
• LC-MS/MS method for the determination of N-nitroso-fluoxetine in fluoxetine tablets

The OMCL at Swissmedic established three LC-MS/MS methods for the determination of specific NDSRIs. The links to the English translated versions are listed below. Please note that the German versions of the SOPs are the official versions.

• LC-MS/MS method for the determination of N-nitroso-hydrochlorothiazide in hydrochlorothiazide preparations
• LC-MS/MS method for determination of N-nitroso-duloxetine in duloxetine preparations
• LC-MS/MS method for the determination of N-nitroso-sertraline in sertraline preparations

Link to the OMCL landing page: Nitrosamine testing activities of the OMCL Network - European Directorate for the Quality of Medicines & HealthCare

[lucas10mauriz]

This development marks a pivotal step forward. By expanding the repertoire of analytical approaches, we not only enhance our understanding of complex issues but also strengthen our ability to address them effectively. The diversity of methodologies equips us with valuable tools to navigate the multifaceted challenges inherent in NDSRIs.