|
About the Limits of Nitrosamines category
|
|
0
|
1072
|
April 14, 2021
|
|
EMA - Appendix 1 - Update
|
|
95
|
9159
|
June 15, 2026
|
|
Finasteride NDSRI
|
|
2
|
100
|
June 15, 2026
|
|
Application of read-across to data-poor N-nitrosamines: N-nitroso-ulifloxacin, a case study-Pub
|
|
0
|
33
|
June 14, 2026
|
|
Rupatadine related Nitrosamine
|
|
0
|
35
|
June 13, 2026
|
|
Calculation of the Maximum Daily Dose (MDD) in Mouthwash Products
|
|
2
|
173
|
June 11, 2026
|
|
Published limit for N-Nitroso-Vonoprazan
|
|
3
|
472
|
May 29, 2026
|
|
Why EMA still assigns AI limits (CPCA) for nitrosamines in oncology drugs
|
|
7
|
399
|
May 27, 2026
|
|
N-Nitroso Perindopril Limit as NMI or 1500ng/day
|
|
3
|
233
|
May 21, 2026
|
|
Regulatory Rationale for Restricting LTL Application to Nitrosamines
|
|
4
|
425
|
May 19, 2026
|
|
EMA's Revision of the Acceptance Limit for N-Nitroso-N-desmethyl-diphenhydramine
|
|
4
|
455
|
April 20, 2026
|
|
Toxycologist ... not for you!
|
|
2
|
239
|
April 17, 2026
|
|
Testing of APIs for NDSRI
|
|
5
|
1327
|
April 12, 2026
|
|
Question on the Method for Determining the Maximum Allowable Daily Usage of Terbinafine Ointment and Solution Formulations
|
|
2
|
173
|
April 2, 2026
|
|
N-Nitrosoatorvastatin and applicable potency category 4 or 5
|
|
2
|
127
|
March 20, 2026
|
|
Request for analytical method support – N-nitroso-piperidine in LVP elastomeric packaging (E&L study)
|
|
0
|
134
|
March 19, 2026
|
|
MEGLUMINE (Methylglucamine)
|
|
28
|
3877
|
March 16, 2026
|
|
EMA Q&A Appendix 1 update posted on 13 March 2026
|
|
1
|
493
|
March 16, 2026
|
|
Calculation of Maximum Daily Dose (MDD) for 2 Strengths
|
|
5
|
338
|
February 17, 2026
|
|
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
|
234
|
February 5, 2026
|
|
Nitrosamine control in Metformin /Vildagliptin DP
|
|
6
|
391
|
February 3, 2026
|
|
TGA updated Established acceptable intake for nitrosamines in medicines on 29 January 2026
|
|
0
|
419
|
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
|
246
|
January 29, 2026
|
|
Approach for N-Nitroso Imatinib Limits: Database vs ICH S9
|
|
5
|
244
|
January 22, 2026
|
|
EMA has updated its AI limits on 01 Aug 2025
|
|
18
|
3184
|
January 21, 2026
|
|
N-nitroso-Impurity C in Metamizol Drug product
|
|
28
|
3085
|
January 21, 2026
|
|
Limit of Common or Small Nitrosamine Impurities in RSM irrespective of any particular MDD
|
|
9
|
366
|
January 21, 2026
|
|
How to determine the AI limit value and LOQ when MDD is less than 880mg?
|
|
1
|
194
|
January 20, 2026
|
|
Deriving safe limits for N-nitroso-bisoprolol by error-corrected next-generation sequencing (ecNGS) and benchmark dose (BMD) analysis, integrated with QM modeling and CYP-docking analysis
|
|
14
|
794
|
January 13, 2026
|
|
Detecting Nitrosamines & Mutagenic Impurities
|
|
0
|
228
|
January 12, 2026
|