EMA-funded project to predict in-vivo mutagenicity / mutagenicity classification
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6
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191
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March 2, 2023
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UHPLC-APCI-TQ-MS analytical method capable of quantifying eight nitrosamine impurities from five different Metformin Formulations -Pub
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1
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109
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March 2, 2023
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确定DNSRI的限度需要同时进行Ames和致癌性实验吗?
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4
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189
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March 2, 2023
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Current threat of nitrosamines in pharmaceuticals and scientific strategies for risk mitigation -Pub
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0
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250
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February 7, 2023
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ISP (Chile) announced the voluntary market withdrawal of Atomoxetine DP (40mg & 80mg) due presence of Nitroso-Atomoxetine
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3
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160
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March 1, 2023
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A Survey of Industrial N-nitrosamine Discharges in Switzerland -Pub
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0
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61
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March 1, 2023
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FDA - Notice on Chantix
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2
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142
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March 1, 2023
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Health Canada - Guideline: Quality (CMC) Draft Guidance - New Drug Submissions & Abbreviated New Drug Submissions
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0
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138
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February 27, 2023
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FDA updated compliance program guidance por inspections
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1
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302
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February 27, 2023
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Anybody inquired about Ramipril, Benzapril, Quinapril?
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0
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129
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February 27, 2023
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👨💻 Nitrosamines Analysis in Solvents by GC-MS/MS
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2
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957
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February 27, 2023
|
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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7
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255
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February 27, 2023
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👋🏻 Fantastic Regulatory Update Europe, US, LATAM
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8
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774
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February 25, 2023
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Formation of Dialkyl-N-nitrosamines in Aqueous Solution: An Experimental Validation of a Conservative Predictive Model and a Comparison of the Rates of Dialkyl and Trialkylamine Nitrosation
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6
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285
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February 25, 2023
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7th Impurities: Genotoxic, Nitrosamine & Beyond Summit 15-16 March- Italy& Online
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5
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243
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February 23, 2023
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EMA Nitrosamine Q&A Rev14 published
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6
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392
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February 23, 2023
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Limit for Nitroso Ciprofloxacin
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20
|
652
|
February 23, 2023
|
The acceptance Intake of Nitroso-Propranolol
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9
|
618
|
February 23, 2023
|
N-nitroso-propranolol?
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18
|
634
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February 22, 2023
|
Fourth Nitrosamine Implementation Oversight Group (NIOG) meeting
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4
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410
|
February 16, 2023
|
2 years after pushing FDA to analyze Nitrosamines, Valisure cited it for failing to comply with federal law
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3
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162
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February 15, 2023
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European Pharmacopoeia Activities on Control of Nitrosamines and other DNA-Reactive Impurities
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4
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199
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February 15, 2023
|
Anybody has working with a Gliclazide nitrosamine?
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3
|
257
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February 14, 2023
|
IPEC Europe announces the availability of the revised “Questionnaire for Excipient Nitrosamines Risk Evaluation” (Version 4, 2022)
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11
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375
|
February 14, 2023
|
Carry over limits for Niitrsoamines
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2
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179
|
February 12, 2023
|
Phathom Pharmaceuticals, Inc received complete response letter from US FDA for its approved Helicobacter pylori drug products due to presence of N-nitroso-vonoprazan (NVP), nitrosamine impurity
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1
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190
|
February 10, 2023
|
The research article published by several industry colleagues
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1
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231
|
February 9, 2023
|
Analytical Testing of Nitrosamines in Drugs and Food
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|
0
|
99
|
February 9, 2023
|
Prediction of Nitrosamine formation from Excipients
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|
19
|
625
|
February 8, 2023
|
N-Nitrosamine Formation in Pharmaceutical Solid Drug Products: Experimental Observations -Pub
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0
|
418
|
February 7, 2023
|