🇦🇺 TGA Australia Published Acceptable intakes for Nitrosamines

Limits of Nitrosamines
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Today, TGA also published acceptable intakes for nitrosamines.
More in alignment with EMA including default TTC as 18 ng/day.

https://www.tga.gov.au/how-we-regulate/monitoring-safety-and-shortages/industry-information-about-specific-safety-alerts-recalls-and-shortages/nitrosamine-impurities-medicines/appendix-1-established-acceptable-intake-nitrosamines-medicines

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Thanks for update of TGA

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This week TGA updated their established acceptable intake for nitrosamines in medicines

https://www.tga.gov.au/how-we-regulate/monitoring-safety-and-shortages/industry-information-about-specific-safety-alerts-recalls-and-shortages/nitrosamine-impurities-medicines/appendix-1-established-acceptable-intake-nitrosamines-medicines

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New (12 compounds)

Nitrosamine Source AI limit (ng/day) CPCA category
N-Nitroso-acebutolol Acebutolol 1500 4
N-Nitroso-buspirone Impurity 1 Buspirone 400 3
N-Nitroso-desmethyl-dimetindene Dimetindene 18 1
N-Nitroso-maprotiline Maprotiline 18 1
N-Nitroso-iminodibenzyl Melipramin (Imipramine) 78000
N-Nitroso-propafenon Propafenon 100 2
N-Nitroso-2,4-thiazole amine Ritonavir 18 1
N-Nitroso-desmethyl-rivastigmine Rivastigmine 100 2
N-Nitroso-N-desmethyl-rizatriptan Rizatriptan 18 1
N-Nitroso-valsartan cyano- desvalerylmethylester Valsartan 100 2
N-Nitroso-vanzacaftor Vanzacaftor 1500 4
N-Nitroso vildagliptin amide impurity Vildagliptin 1500 5

Updated (4 compounds)

Nitrosamine Source AI limit (ng/day) CPCA category
N-Nitroso-ciprofloxacin Ciprofloxacin NMI
N-Nitroso-diclofenac Diclofenac 78000
N-Nitroso-nortriptyline Amitriptyline, Nortriptyline 18 1
N-Nitroso-sertraline Sertraline 100 2

appendix-1-established-acceptable-intake-nitrosamines-medicines.pdf (128.3 KB)

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