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🇪🇺 EMA Q&A Rev. 18 EMA/409815/2020 - Deadlines
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2
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1331
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October 3, 2023
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Managing Nitrite Impurities: A Combined Supplier-Manufacturer View to Nitrosamine Risks
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3
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1019
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October 3, 2023
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Uso de herramientas in-silico para Nitrosaminas
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0
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420
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October 2, 2023
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Variation requirements
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2
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449
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October 2, 2023
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关于2023药物杂质控制国际交流会的资讯
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1
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483
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September 29, 2023
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🇺🇸 FDA - Recommended Acceptable Intake Limits for NDSRIs Guidance for Industry
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47
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7220
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September 20, 2023
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Nitrosamine in DS and DP specifications
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2
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854
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September 20, 2023
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WHO on Nitrosamines, Rifampicin, Rifapentine and NDSRIS
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3
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1248
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September 20, 2023
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Nitrosamines risk assessments for Topical herbal extracts
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1
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519
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September 20, 2023
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N-nitroso-duloxetine
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1
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606
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September 19, 2023
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Nitrosamines without published AI, and possibly negative for carcinogenicity
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9
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1038
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September 18, 2023
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Nitrosamines in Biologics
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1
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676
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September 18, 2023
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Apixaban Drug Substance-Related Impurities (NDSRIs)
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3
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1499
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September 15, 2023
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Risk assessments of nitrosamine in two-phase systems
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2
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502
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September 14, 2023
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Nitrite Detection at Picogram Level, is it possible?
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4
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1094
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September 14, 2023
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Enhanced Ames Test Conditions for N-nitrosamines (Q&A Rev.16)
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9
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3235
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September 13, 2023
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🇪🇺 EMA Q&A Rev. 16 EMA/409815/2020 - MAJOR UPDATE
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108
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24642
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September 12, 2023
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Omission of specification <10% AI
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2
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1000
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September 12, 2023
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Azido impurities by APCI-LC-MS
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8
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711
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September 10, 2023
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Identifying the Risk of Formation of Nitrosamines and Other Potentially Mutagenic Impurities during API Manufacture Using In Silico Risk Assessment -Pub
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0
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1163
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June 6, 2023
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A deep dive into historical Ames study data for N-nitrosamine compounds -Pub
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0
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452
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September 8, 2023
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Quantitation of Reactive Nitrosating Agents in Pharmaceutical Excipients for N‑Nitrosamine Risk Assessments
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4
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1258
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September 7, 2023
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Read-across/SAR posts Collection
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10
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2962
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September 7, 2023
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Kinetic model to estimate the amount of nitrosamines
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5
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891
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September 6, 2023
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Fifth Nitrosamine Implementation Oversight Group (NIOG) – meeting with pharmaceutical industry
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1
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669
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September 6, 2023
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Singapore: HSA issues retail-level recalls for batches of Apo-Amitriptyline and Apo-Acyclovir tablets due to nitrosamine impurity concerns
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0
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597
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September 4, 2023
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Apotex Inc. Canada is recalling one lot of APO-Amitriptyline due to presence of nitrosamine impurity, N-nitrosodimethylamine (NDMA) above the acceptable limit at the 48-month stability testing timepoint
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15
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1518
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September 3, 2023
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Forced Degradation and the NAP test
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3
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739
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September 2, 2023
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DP Method transfer and verification
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8
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755
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August 31, 2023
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Higher limits allowed by FDA for Nitroso-sitagliptin
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20
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4878
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August 28, 2023
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