|
Terbinafine Nitrosamines
|
|
3
|
374
|
November 14, 2024
|
|
NDSRI limit for N-nitroso Ciprofloxacin
|
|
2
|
422
|
November 1, 2024
|
|
FDA Statement on Ritonavir and NITMA
|
|
1
|
459
|
October 29, 2024
|
|
Hexamethyldisilazane (HMDS) can form Nitrosamine Impurity?
|
|
7
|
740
|
October 29, 2024
|
|
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
|
|
0
|
369
|
October 28, 2024
|
|
Nitroso Betahistine Impurity C
|
|
2
|
203
|
October 28, 2024
|
|
Use of L-cysteine as nitrite scavenging
|
|
6
|
645
|
October 25, 2024
|
|
Selection of Solvent and Positive Control Concentration for Enhanced AMES Test -Pub
|
|
0
|
147
|
October 14, 2024
|
|
Oral Liquid Formulations
|
|
4
|
334
|
October 14, 2024
|
|
🇸🇦 Saudi FDA requesting Nitrosamines Risk Assessments
|
|
5
|
1969
|
October 9, 2024
|
|
Dietary exposure assessment for volatile N-nitrosamines from food and beverages for the U.S. population -Pub
|
|
0
|
162
|
September 18, 2024
|
|
NDMA testing in metformin
|
|
5
|
337
|
September 9, 2024
|
|
Vildaglibtin and Metformin in combinationy
|
|
1
|
585
|
October 17, 2023
|
|
USP - CPCA Nitrosamines Case Study
|
|
7
|
1707
|
August 30, 2024
|
|
Resources to help educate reluctant excipient suppliers?
|
|
7
|
396
|
August 28, 2024
|
|
Seventh European Medicines Agency - Medicines for Europe annual bilateral meeting
|
|
1
|
160
|
August 27, 2024
|
|
Analytical methodologies to detect N-nitrosamine impurities in active pharmaceutical ingredients, drug products and other matrices -Pub
|
|
0
|
546
|
August 27, 2024
|
|
🇧🇷 Guideline for the control of Nitrosamines Rev. 4
|
|
24
|
2449
|
August 21, 2024
|
|
AI for NDSRI by Brazil regulatory
|
|
6
|
1047
|
August 7, 2024
|
|
South African Health Products Regulatory Authority (Nitrosamines)
|
|
2
|
806
|
August 5, 2024
|
|
👨💻 Dashboard Containing Published AI Limits
|
|
31
|
4346
|
August 2, 2024
|
|
🇲🇽 Coming July Mexico Nitrosamines Guideline
|
|
4
|
554
|
August 2, 2024
|
|
Extension of the implementation deadline for "Self-inspection on Risks of Contamination with Nitrosamines in Drug" in Japan
|
|
2
|
334
|
July 30, 2024
|
|
The clinical and regulatory status of NDSRI: A global imperative -Pub
|
|
1
|
316
|
July 30, 2024
|
|
EMA/CHMP Concept paper on the revision of the guideline on the chemistry of active substances
|
|
4
|
651
|
July 29, 2024
|
|
Swissmedic updated requirements for dealing with potential nitrosamine impurities in medicinal products
|
|
2
|
646
|
February 1, 2024
|
|
Development and Manufacture of Oligonucleotides + Nitrosamines
|
|
0
|
370
|
July 24, 2024
|
|
🇪🇺 EMA/409815/2020 Rev.21 (19-Jul-24)
|
|
1
|
4479
|
July 22, 2024
|
|
ICH M7 plans to harmonize AI limits for Nitrosamines
|
|
0
|
370
|
June 13, 2024
|
|
Nitrosamines in food raise a health concern (EFSA)
|
|
7
|
1262
|
June 11, 2024
|