29-30 April 2025
Coventry Building Society Arena
Nitrosamine Impurities testing: from EMA updates on Nitroso-API to real case study
Time: 10:50 am - 11:10 am
Date: 30 April 2025
Theatre: Room D
30-april-2025 10:50
30-april-2025 11:10
Europe/London
Nitrosamine Impurities testing: from EMA updates on Nitroso-API to real case study
The presentation will aim to illustrate the regulatory evolutions related to NAs, moving from general ones to nitroso APIs. The crucial point will be the analytical approach to the different matrices in function of the MDD of the drugs and the different limits foreseen for each impurity. The presentation will also include different case studies.
Making PharmaceuticalsSynopsis
The presentation will aim to illustrate the regulatory evolutions related to NAs, moving from general ones to nitroso APIs. The crucial point will be the analytical approach to the different matrices in function of the MDD of the drugs and the different limits foreseen for each impurity. The presentation will also include different case studies.
Speakers
Dr Caterina Cappuccini Quality Control Manager - Neotron Pharma
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