Lonza Capsugel Launched Nitrosamine Risk Service
The new testing service provides critical nitrite quantification to help drug manufacturers meet updated EMA safety standards.
Updated on Sept. 28, 2026 in Biotech
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Lonza Capsugel has launched a new service to conduct nitrite testing, data analysis, and regulatory support for pharmaceutical manufacturers. The service is designed to mitigate the formation of nitrosamine impurities in drug products, which the FDA has identified as a potential risk stemming from excipients.
Why it matters
Nitrites act as precursors to nitrosamine formation, posing a significant challenge for drug stability and safety. By providing standardized quantification, this service helps manufacturers develop required risk management strategies in response to evolving regulatory requirements.
The service achieves a nitrite quantification limit of 100 ppb using ion chromatography—a technique that separates ions based on their affinity to an ion exchanger—combined with Griess derivatisation to visualize nitrite content. The analytical process is validated according to ICH Q2(R2) principles to manage matrix-specific extractions.
The players
Lonza Capsugel
A provider of specialized delivery technologies and manufacturing services for the global pharmaceutical industry.
FDA
The United States federal agency responsible for regulating food and drug safety, including pharmaceutical manufacturing standards.
EMA
The European Union agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines.
The details
The service addresses the risk of nitrosamine formation, where nitrites react with drug active pharmaceutical ingredients (APIs). By utilizing ion chromatography with Griess derivatisation—a chemical process that turns nitrites into a colored compound for detection—the method identifies residual nitrites in excipients. It is specifically engineered to handle potential analytical interferences that often complicate testing for these compounds in complex pharmaceutical matrices.
Timeline
October 2025: The EMA updated its nitrosamine guidance.
June 2026: The EMA updated its acceptable intake information.
September 28, 2026: Lonza Capsugel launched the testing service.
The Tech Race
This service arrives as global manufacturers scramble to align with the EMA nitrosamine guidance updated in October 2025. It represents a pivot toward providing integrated regulatory solutions to meet the increasingly stringent safety standards established by the EMA in June 2026.
Pharmaceutical manufacturers can now utilize this validated method to perform the risk assessments required to maintain compliance for existing drug products. The service helps developers integrate standardized impurity testing directly into their product-specific nitrosamine management strategies.
The takeaway
The move underscores the growing necessity for precise chemical screening as regulators tighten limits on drug impurities. Watch for upcoming industry adoption rates of ICH Q2(R2)-validated methods as manufacturers navigate the next round of EMA regulatory filings.
Further reading
Explore more analysis regarding drug safety and manufacturing technologies on our Biotech section.
Source note: This article includes information reported by Manufacturingchemist.
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