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About the Limits of Nitrosamines category
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0
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1068
|
April 14, 2021
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Calculation of the Maximum Daily Dose (MDD) in Mouthwash Products
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1
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84
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June 10, 2026
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EMA - Appendix 1 - Update
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89
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8825
|
June 10, 2026
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Published limit for N-Nitroso-Vonoprazan
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3
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464
|
May 29, 2026
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Why EMA still assigns AI limits (CPCA) for nitrosamines in oncology drugs
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7
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389
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May 27, 2026
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N-Nitroso Perindopril Limit as NMI or 1500ng/day
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3
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232
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May 21, 2026
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Regulatory Rationale for Restricting LTL Application to Nitrosamines
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4
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418
|
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
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451
|
April 20, 2026
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Toxycologist ... not for you!
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2
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239
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April 17, 2026
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Testing of APIs for NDSRI
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5
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1319
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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
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168
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April 2, 2026
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N-Nitrosoatorvastatin and applicable potency category 4 or 5
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2
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127
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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
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132
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March 19, 2026
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MEGLUMINE (Methylglucamine)
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28
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3853
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March 16, 2026
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EMA Q&A Appendix 1 update posted on 13 March 2026
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1
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478
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March 16, 2026
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Calculation of Maximum Daily Dose (MDD) for 2 Strengths
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5
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337
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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
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1
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231
|
February 5, 2026
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Nitrosamine control in Metformin /Vildagliptin DP
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6
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386
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February 3, 2026
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TGA updated Established acceptable intake for nitrosamines in medicines on 29 January 2026
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0
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413
|
January 29, 2026
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Nitrosamine Drug Substance-Related Impurities cause DNA methylation adducts in vitro and in primary hepatocytes upon Cytochrome P450-dependend metabolic activation-Pub
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2
|
246
|
January 29, 2026
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Approach for N-Nitroso Imatinib Limits: Database vs ICH S9
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5
|
238
|
January 22, 2026
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EMA has updated its AI limits on 01 Aug 2025
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18
|
3162
|
January 21, 2026
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N-nitroso-Impurity C in Metamizol Drug product
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28
|
3073
|
January 21, 2026
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Limit of Common or Small Nitrosamine Impurities in RSM irrespective of any particular MDD
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9
|
358
|
January 21, 2026
|
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How to determine the AI limit value and LOQ when MDD is less than 880mg?
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1
|
190
|
January 20, 2026
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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
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14
|
785
|
January 13, 2026
|
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Detecting Nitrosamines & Mutagenic Impurities
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0
|
226
|
January 12, 2026
|
|
How to Establish MDD for Creams and Ophthalmic Solutions
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|
4
|
383
|
January 8, 2026
|
|
Nitrosamine Impurities in Excipients
|
|
11
|
566
|
January 8, 2026
|
|
Limits more than one Nitrosamine?
|
|
45
|
3440
|
December 30, 2025
|