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).
Subject area:
Drug Products & APIs
Objectives (If applicable):
N/a
Target Audience (If applicable):
• Analytical R&D scientists
• QC scientists (DS, DP)
• QC managers
• QA staff who authorizes drug product release
• Regulators affairs staff