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Hexamethyldisilazane (HMDS) can form Nitrosamine Impurity?
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7
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541
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October 29, 2024
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N-Nitrosamine drug substance related impurities (NDSRIs) – 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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281
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October 28, 2024
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Nitroso Betahistine Impurity C
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2
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143
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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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292
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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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114
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October 14, 2024
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Oral Liquid Formulations
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4
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203
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October 14, 2024
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🇸🇦 Saudi FDA requesting Nitrosamines Risk Assessments
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5
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1751
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October 9, 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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118
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September 18, 2024
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NDMA testing in metformin
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5
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243
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Vildaglibtin and Metformin in combinationy
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1
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551
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October 17, 2023
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USP - CPCA Nitrosamines Case Study
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7
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1527
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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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344
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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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106
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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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373
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August 27, 2024
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🇧🇷 Guideline for the control of Nitrosamines Rev. 4
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24
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1823
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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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911
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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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715
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August 5, 2024
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👨💻 Dashboard Containing Published AI Limits
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32
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3734
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August 2, 2024
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🇲🇽 Coming July Mexico Nitrosamines Guideline
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5
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487
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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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223
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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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277
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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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601
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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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2
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531
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February 1, 2024
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Development and Manufacture of Oligonucleotides + Nitrosamines
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0
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288
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July 24, 2024
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🇪🇺 EMA/409815/2020 Rev.21 (19-Jul-24)
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1
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3136
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July 22, 2024
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ICH M7 plans to harmonize AI limits for Nitrosamines
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1
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321
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June 13, 2024
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Nitrosamines in food raise a health concern (EFSA)
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7
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1095
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June 11, 2024
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Update: EFPIA workflows for Quality Risk management Jun 2024 v03
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2
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980
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June 4, 2024
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🇰🇷 Case study on the Occurrence of Impurities in Pharmaceuticals (Focusing on NDMA Cases)
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0
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356
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May 31, 2024
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Justify the presence of amine in the API chemical structure
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3
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317
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May 29, 2024
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