Advantages and limitations of the inclusion of ascorbic acid on nitrosamine mitigation in pharmaceutical drug products

Key Points

• Ascorbic acid effectively reduces nitrosamines, improving drug product safety and stability.
• The study noted a significant decrease in nitrosamine levels, with a 50% reduction after ascorbic acid incorporation.
• Assessment of the impact on stability and reactivity was carried out using controlled experiments.
• These findings may indicate potential improvements in pharmaceutical formulations for broader applications.