Senior Toxicology Officer
9 articles
Learn about nitrosamine impurities in medicinal products, their causes, regulatory guidance, and strategies for risk evaluation and mitigation.
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On 01/12/2025, the European Medicines Agency (EMA) released an update to Appendix 1 (EMA/42261/2025/Rev. 11) of the Nitrosamines Guideline. This appendix lists nitrosamines for which an established Acceptable Intake (AI) is available.
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Learn key takeaways from a real-world nitrosamine reporting case. Discover how pharma companies can move from compliance to proactive risk management.
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On June 23, 2025, the FDA released a clarification regarding the upcoming August 1, 2025 deadline related to nitrosamine drug substance-related impurities (NDSRIs).
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On 17 May 2025, the European Medicines Agency (EMA) released Revision 22 of its Nitrosamines Q&A document (EMA/409815/2020), bringing key updates for pharmaceutical manufacturers and regulatory professionals.
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Explore essential toxicological monitoring tests, including E&L, Nitrosamine Analysis, and Ames Test, to ensure safety and meet regulatory standards.
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The FDA has just released an updated version of its Control of Nitrosamine Impurities in Human Drugs Guidance, introducing crucial changes for pharmaceutical manufacturers.
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On 04/07/2024, the European Medicines Agency (EMA) released an update to Appendix 1 (EMA/154403/2024 /Rev. 5) of the Nitrosamines Guideline. In this Appendix the different nitrosamines that have an established Acceptable Intake (AI) are listed.
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On 01/05/2024, the European Medicines Agency (EMA) rolled out an update to Appendix 1 (EMA/154403/2024 /Rev. 4) of the Nitrosamines Guideline. In this Appendix the different nitrosamines that have an established Acceptable Intake (AI) are listed. This update particularly impacts medicines containing any of the active substances listed above in their formulation.
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