2025 And Beyond - A Look At Upcoming NDSRI Regulations

The pharmaceutical industry faces an urgent challenge with nitrosamine drug substance-related impurities (NDSRIs) in medications. In response, the FDA issued new guidance in August 2023, establishing strict acceptable intake (AI) limits for NDSRIs. Manufacturers must ensure compliance by August 1, 2025, or risk substantial fines, legal issues, and costly recalls.

To meet these requirements, companies must conduct thorough risk assessments to identify potential sources of nitrosamine contamination, such as raw materials and equipment. Confirmatory testing using sensitive and validated methods is crucial for verifying that NDSRI levels are within the FDA's AI limits. If levels exceed these limits, corrective actions like reformulating products or tightening controls are necessary.

Partnering with a reliable nitrosamine testing provider is essential. SK pharmteco offers advanced testing services, with expertise in detecting and quantifying nitrosamines, rapid turnaround times, and low detection limits. Their support helps companies navigate these regulations effectively, avoid compliance risks, and meet the 2025 deadline. Continuous vigilance and adaptation will be critical for addressing ongoing NDSRI challenges.