About the Guidance, Documents, Resources category
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0
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498
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April 14, 2021
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NDSRI limit for N-nitroso Ciprofloxacin
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2
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98
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November 1, 2024
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πΊπΈ FDA Control of Nitrosamine Impurities in Human Drugs revision2
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32
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1909
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October 30, 2024
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FDA Statement on Ritonavir and NITMA
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1
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103
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October 29, 2024
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Hexamethyldisilazane (HMDS) can form Nitrosamine Impurity?
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7
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477
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October 29, 2024
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N-Nitrosamine drug substance related impurities (NDSRIs) β A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular weight > 200 Da -Pub
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0
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103
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October 28, 2024
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Nitroso Betahistine Impurity C
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2
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91
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October 28, 2024
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Use of L-cysteine as nitrite scavenging
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6
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195
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October 25, 2024
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Selection of Solvent and Positive Control Concentration for Enhanced AMES Test -Pub
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0
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92
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October 14, 2024
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Oral Liquid Formulations
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4
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163
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October 14, 2024
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πΈπ¦ Saudi FDA requesting Nitrosamines Risk Assessments
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5
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1597
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October 9, 2024
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π²π½ Mexico Nitrosamine Guide published today
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22
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1931
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September 24, 2024
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Dietary exposure assessment for volatile N-nitrosamines from food and beverages for the U.S. population -Pub
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0
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104
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September 18, 2024
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NDMA testing in metformin
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5
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190
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September 9, 2024
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Vildaglibtin and Metformin in combinationy
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2
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520
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September 8, 2024
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USP - CPCA Nitrosamines Case Study
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7
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1413
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August 30, 2024
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Resources to help educate reluctant excipient suppliers?
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7
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318
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August 28, 2024
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ICH M7 & Nitrosamines Impurities -Updates
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11
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2555
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August 28, 2024
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Seventh European Medicines Agency - Medicines for Europe annual bilateral meeting
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1
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98
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August 27, 2024
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Analytical methodologies to detect N-nitrosamine impurities in active pharmaceutical ingredients, drug products and other matrices -Pub
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0
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194
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August 27, 2024
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π§π· Guideline for the control of Nitrosamines Rev. 4
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24
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1339
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August 21, 2024
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AI for NDSRI by Brazil regulatory
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6
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793
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August 7, 2024
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South African Health Products Regulatory Authority (Nitrosamines)
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2
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682
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August 5, 2024
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π¨βπ» Dashboard Containing Published AI Limits
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32
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3422
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August 2, 2024
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π²π½ Coming July Mexico Nitrosamines Guideline
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5
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452
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August 2, 2024
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Extension of the implementation deadline for "Self-inspection on Risks of Contamination with Nitrosamines in Drug" in Japan
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2
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155
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July 30, 2024
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The clinical and regulatory status of NDSRI: A global imperative -Pub
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1
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231
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July 30, 2024
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EMA/CHMP Concept paper on the revision of the guideline on the chemistry of active substances
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4
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582
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July 29, 2024
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Swissmedic updated requirements for dealing with potential nitrosamine impurities in medicinal products
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3
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494
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July 28, 2024
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Development and Manufacture of Oligonucleotides + Nitrosamines
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0
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248
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July 24, 2024
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