Course Description:
Nitrosamines are a critical topic for regulators and industry given the recent safety recalls of several products containing these impurities.
This video product is designed to provide step-by-step tutorials of laboratory methods described in the USP General Chapter <1469> Nitrosamines Impurities course. Tutorials emphasize key considerations, challenges, and recommendations for troubleshooting each procedure (varies from instrument to instrument). Who should participate:
- Analytical R&D scientists
- QC scientists (DS, DP)
- QC managers
- QA staff who authorizes drug product release
- Regulators affairs staff
Nitrosamines Courses and USP Reference Standards (RS) Promotion
USP <1469> On-Demand Video Tutorials” and USP Reference Standards for Nitrosamines
View USP Nitrosamines-Related Drug Substances Catalog - Includes over 54 Nitrosamines-Related Drug Substance Impurities (NDSRIs).
All Nitrosamines RS in USP Store – Includes over 65 Nitrosamines RS
Access to this course expires 6 months from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Speakers:
Video Procedure 1: Qiyao Li, Scientist IV, ADL
Video Procedure 2: Eswara Raju Kosuri, Sr. Scientist II, CDL
Video Procedure 3: Allan T. Leeks, Scientist IV, ADL
Video Procedure 4: Anindita Sarkar, Sr. Manager, CDL