Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation
Risk control for nitrosamine impurities in drug products is currently a major challenge in the industry. Nitrosamines can form during drug product manufacturing and storage through the reaction of nitrites with amine-containing APIs or impurities. The level of nitrites in excipients and the rate of...
Saved in:
| Main Authors: | , , |
|---|---|
| Format: | Book |
| Published: |
MDPI AG,
2023-07-01T00:00:00Z.
|
| Subjects: | |
| Online Access: | Connect to this object online. |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|