πŸ‡¦πŸ‡Ί TGA - Latest Update to Nitrosamine Limits

Limits of Nitrosamines
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The TGA in Australia :australia: have updated their list of nitrosamine limits again last week - see the link below.

Appendix 1 - Established acceptable intake for nitrosamines in medicines | Therapeutic Goods Administration (TGA)

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Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies

Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies | Organic Process Research & Development (acs.org)

A paper by Răzvan C. Cioc et al (EMA) provides a good consolidation of current information on possible risk factors