NDBA Nitrosamine analysis and the FDA alert: a major issue for the Pharmaceutical Industry
What is N-nitroso-dibutylamine (NDBA)?
Nitrosamines are chemical compounds known for their carcinogenic potential.
N-Nitroso-dibutylamine (NDBA) is a compound in the nitrosamine family and can be formed during the manufacturing or storage of certain pharmaceutical products.
The presence of NDBA in drugs packaged in infusion bags raises significant regulatory compliance concerns for pharmaceutical manufacturers.
The recent FDA alert: key issues and dates
On August 18, 2025, the FDA confirmed the detection of NDBA in certain infusion bags. This announcement triggered an obligation for manufacturers to reevaluate their processes and materials to avoid any risk of contamination. The challenge is twofold:
- Patient safety: preventing exposure to potentially harmful substances
- Regulatory compliance: documenting and communicating to authorities the measures taken to limit nitrosamines
Obligations for manufacturers
In response to this alert, manufacturers must implement several measures:
- Evaluation of packaging materials: films, outer bags, inks, and other components must be analyzed to detect any risk of nitrosamine formation.
- Ultra-sensitive analysis: nitrosamines are active at ultra-trace levels (ppb), requiring sophisticated analytical techniques.
- Documentation and traceability: all actions and results must be recorded and communicated to the relevant authorities.
These steps are essential to comply with FDA requirements.
Ultra-sensitive nitrosamine analysis and support from an expert nitrosamine laboratory
As an analysis and expertise laboratory, FILAB offers:
- Determination of ultra-trace nitrosamines using our state-of-the-art equipment
- Characterization of materials and inks to identify potential sources of contamination
- Comprehensive scientific support to guide you through your regulatory procedures and audits
Our expertise allows you to respond quickly and efficiently to FDA requirements.
