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Health Canada - Guideline: Quality (CMC) Draft Guidance - New Drug Submissions & Abbreviated New Drug Submissions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