Limits
| Topic | Replies | Views | Activity | |
|---|---|---|---|---|
| 🇺🇸 FDA updates 'estimated duration' dates on Recommended Interim AI limits |
|
1 | 24 | August 3, 2026 |
| N-Nitroso Perindopril Limit as NMI or 1500ng/day |
|
3 | 259 | May 21, 2026 |
| 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 | 362 | October 28, 2024 |
| 🖩 CPCA Calculation Tool (excel-based) -Updated |
|
87 | 13220 | September 27, 2024 |
| 🇺🇸 FDA - Updated information on recommended AI for NDSRIs (23/Feb/2024) - Tables 2 & 3 |
|
16 | 4646 | July 28, 2024 |
| CPCA Calculation System (Python Desktop) |
|
1 | 1665 | November 22, 2023 |
| AI for NDSRIs with positive EAT and/or in-vivo mutagenicity study - FDA position? |
|
2 | 742 | November 9, 2023 |