TGA
Consistent with recent EMA updates of acceptable intakes for established N-nitrosamines, the TGA has published updated acceptable intakes for nitrosamines in medicines.
- Include several CAS RNs and minor editorial amendments
- Include an AI limit for N-nitroso-desmethyl- sildenafil of 400 ng/day in Sildenafil
- Include the AI limit for 1-(2,3-dichlorophenyl)-4-nitrosopiperazine of 400 ng/day in Aripiprazole
- Include the AI limit for N-nitroso-urapidil of 1500 ng/day in Uradipil
- Include the AI limit for N-nitroso-mirtazapine of 400 ng/day in Mirtazapine
- Include the AI limit for N-nitroso ranolazine impurity 1 of 400 ng/day in Ranolazine
- Include the AI limit for N-nitroso-rivaroxaban open-ring acid of 1500 ng/day in Rivaroxaban
- Include the AI limit for N-nitroso-rivaroxaban amide of 1500 ng/day in Rivaroxaban
- Include the AI limit for N-nitroso-desmethyl sumatriptan of 18 ng/day in Sumatriptan
- Include the AI limit for N-nitroso-azacyclonol of 400 ng/day in Azacyclonol
- Include the AI limit for N-nitroso-betaxolol of 1500 ng/day in Betaxolol
- Include the AI limit for N-nitroso-ribociclib impurity 1 of 400 ng/day in Ribociclib
- Include the AI limit for N-nitroso-desmethyl-terbinafine (NDT) of 18 ng/day in Terbinafine
- Include the AI limit for N-nitroso-terbinafine impurity A (NTA) of 18 ng/day in Terbinafine
- Include the AI limit for N-nitroso-terbinafine degradant (NTD) of 18 ng/day in Terbinafine
- Include the AI limit for N-nitroso dorzolamide of 1500 ng/day in Dorzolamide
- Include the AI limit for N-Nitroso-desmethyl-azelastine of 100 ng/day in Azelastine
- Include the AI limit for N-nitroso-celiprolol of 1500 ng/day in Celiprolol
- Include the AI limit for N-nitroso-cinacalcet of 400 ng/day in Cinacalcet
- Include the AI limit for 5-chloro-4-methyl-2-[(2S)-2-methyl-1-nitrosopyrrolidin-2-yl]-1H-benzimidazole (IDOR-1135-8758) of 1500 ng/day in Daridorexant
- Include the AI limit for N-nitroso-desmethyl-citalopram of 18 ng/day in Citalopram
- Include the AI limit for N-nitroso-desvenlafaxine of 18 ng/day in Desvenlafaxine
- Include the AI limit for N-nitroso-esmolol of 1500 ng/day in Esmolol
- Include the AI limit for N-nitroso-calcium folinate of NMI in Calcium folinate / Calcium levofolinate
- Include the AI limit for N-nitroso imatinib of 1500 ng/day in Imatinib
- Include the AI limit for Indapamide impurity A / 2-methyl-1-nitroso-2,3-dihydroindole of 1500 ng/day in Indapamide
- Include the AI limit for N-nitroso-ethylenediamine-triacetic acid of 1500 ng/day in Isosorbide mononitrate
- Include the AI limit for N-nitroso-iminodiacetic acid of 1500 ng/day in Isosorbide mononitrate
- Include the AI limit for N-nitroso-leniolisib of 1500 ng/day in Leniolosib
- Include the AI limit for N-nitroso-desethyllidocaine of 100 ng/day in Lidocaine / Lignocaine
- Include the AI limit for N-nitroso desmethyl nintedanib of 400 ng/day in Nintedanib
- Include the AI limit for N-nitroso-N-methylaniline / N-methyl-N-phenylnitrous amide (NMPA) of 100 ng/day
- Include the AI limit for N-nitroso quetiapine HEEP impurity / 2-(2-(4-nitrosopiperazin-1-yl)ethoxy)ethan-1-ol of 1500 ng/day in Quetiapine
- Include the AI limit for N-nitroso-tetracaine of 400 ng/day in Tetracaine
- Include the AI limit for N‐nitroso‐ticagrelor of 1500 ng/day in Ticagrelor
- Republish the AI limit of ng/day for N-nitroso-piperazine (NPZ)
- Increase the AI limit for N-nitroso-dabigatran etexilate from 400 ng/day to 1500 ng/day in Dabigatran etexilate
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