The deadline may have moved, but the countdown still continues.

It’s good news for pharma companies that the deadline for risk assessment on nitrosamines has been extended to October 1st. However, with the shutdown of many sites due to the COVID-19 pandemic, that could still be a challenge for many.

The European Medicines Agency has now agreed to extend the deadline for the submission of risk evaluations to 1 October 2020. As before, MAHs are obliged to inform the national competent authorities as soon as possible if tests confirm the presence of nitrosamine, irrespective of the amount detected.

Based on this directive, now more than ever, it’s imperative to choose a partner who is set up with a dedicated team, capability to work quickly and professionally within the new timeline, and with the correct expertise to properly conduct a risk evaluation which can identify active substances and finished products at risk of N-nitrosamine formation or (cross-)contamination.

Get in touch with us to learn how QUINTA-ANALYTICA can help with such testing using our isotopically labeled standard detection methods for APIs, solid dosage forms, solutions for infusion, oral solutions, semi-finished products and more.

Additional News

  • 18 September 2024

    Determination of total bound iron in human blood serum samples

    Ironing out the challenges: measuring total bound iron in blood serum in Ferric Carboxymaltose (FCM) Studies

  • 4 September 2024

    Meet us at the heart of Pharma at CPHI 2024

    As a part of Conscio Group, we are attending CPHI 2024 in Milan, Italy.

  • 18 March 2024

    News from our newly opened clinic in Ostrava

    Our new Clinic in Ostrava (CZ) is gaining momentum step by step; therefore, we have some interesting news for you from the center of the action.