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About the Limits of Nitrosamines category
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0
|
1101
|
April 14, 2021
|
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Nitrosamine risk assessment for short-term therapies: lifetime assumptions versus less-than-lifetime (LTL) exposure
|
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2
|
172
|
August 4, 2026
|
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AI limit for N-nitroso betahistine?
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32
|
4769
|
July 23, 2026
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Establishment of Limits in ppm (mg/kg) for Drug Products
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2
|
249
|
July 22, 2026
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MEGLUMINE (Methylglucamine)
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31
|
4312
|
July 20, 2026
|
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Use of conversion factors
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5
|
466
|
July 14, 2026
|
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Deactivation feature on a 8-member ring with side chains?
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7
|
221
|
July 9, 2026
|
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Nitrosamine limits in pediatric populations
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4
|
278
|
June 30, 2026
|
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Application of read-across to data-poor N-nitrosamines: N-nitroso-ulifloxacin, a case study-Pub
|
|
1
|
158
|
June 16, 2026
|
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Calculation of the Maximum Daily Dose (MDD) in Mouthwash Products
|
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3
|
252
|
June 16, 2026
|
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Rupatadine related Nitrosamine
|
|
1
|
127
|
June 15, 2026
|
|
EMA - Appendix 1 - Update
|
|
94
|
10340
|
June 15, 2026
|
|
Finasteride NDSRI
|
|
2
|
179
|
June 15, 2026
|
|
Published limit for N-Nitroso-Vonoprazan
|
|
3
|
514
|
May 29, 2026
|
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Why EMA still assigns AI limits (CPCA) for nitrosamines in oncology drugs
|
|
7
|
477
|
May 27, 2026
|
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N-Nitroso Perindopril Limit as NMI or 1500ng/day
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|
3
|
266
|
May 21, 2026
|
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Regulatory Rationale for Restricting LTL Application to Nitrosamines
|
|
4
|
506
|
May 19, 2026
|
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EMA's Revision of the Acceptance Limit for N-Nitroso-N-desmethyl-diphenhydramine
|
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4
|
492
|
April 20, 2026
|
|
Toxycologist ... not for you!
|
|
2
|
255
|
April 17, 2026
|
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Testing of APIs for NDSRI
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|
5
|
1420
|
April 12, 2026
|
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Question on the Method for Determining the Maximum Allowable Daily Usage of Terbinafine Ointment and Solution Formulations
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2
|
202
|
April 2, 2026
|
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N-Nitrosoatorvastatin and applicable potency category 4 or 5
|
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2
|
149
|
March 20, 2026
|
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Request for analytical method support – N-nitroso-piperidine in LVP elastomeric packaging (E&L study)
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|
0
|
151
|
March 19, 2026
|
|
EMA Q&A Appendix 1 update posted on 13 March 2026
|
|
1
|
624
|
March 16, 2026
|
|
Calculation of Maximum Daily Dose (MDD) for 2 Strengths
|
|
5
|
385
|
February 17, 2026
|
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Ames Concordance with the In Vivo Transgenic Rodent (TGR) Gene Mutation Assay for NDSRIs and Relative In Vivo TGR Potency with Nitrosamines with Robust Dose-Response Carcinogenicity Data-Pub
|
|
1
|
252
|
February 5, 2026
|
|
Nitrosamine control in Metformin /Vildagliptin DP
|
|
6
|
436
|
February 3, 2026
|
|
TGA updated Established acceptable intake for nitrosamines in medicines on 29 January 2026
|
|
0
|
471
|
January 29, 2026
|
|
Nitrosamine Drug Substance-Related Impurities cause DNA methylation adducts in vitro and in primary hepatocytes upon Cytochrome P450-dependend metabolic activation-Pub
|
|
2
|
273
|
January 29, 2026
|
|
Approach for N-Nitroso Imatinib Limits: Database vs ICH S9
|
|
5
|
279
|
January 22, 2026
|