Lonza Capsugel has announced the launch of an integrated service designed to help pharmaceutical manufacturers assess and manage nitrosamine risks associated with nitrite levels in empty capsules.
The new offering combines nitrite testing, scientific interpretation, capsule and formulation expertise, as well as regulatory support in a single service.
Nitrites can act as precursors to nitrosamine formation in drug products, adding another consideration for manufacturers conducting product-specific nitrosamine risk assessments.
The US FDA has highlighted residual nitrites in excipients as a potential source of nitrosamine drug substance-related impurities (NDSRIs), which can form when nitrites react with susceptible API structures.
Lonza Capsugel said its service is intended to help manufacturers generate data that can be used to determine an appropriate nitrite risk-management strategy.
Services include nitrite testing, data interpretation, regulatory documentation, scientific consultation, risk investigations and collaborative studies to support discussions with regulators.
Capsule-specific nitrite analysis
At the centre of the offering is a nitrite quantification method developed specifically for the gelatin capsule matrix.
The method uses ion chromatography with Griess derivatisation and has been validated according to ICH Q2(R2) principles, with a reported quantification capability down to 100 ppb.
Lonza said the approach addresses matrix-specific extraction, selectivity and potential analytical interferences, enabling sensitive nitrite measurements for capsule and comparative testing.
The development comes as regulatory expectations around nitrosamine impurities continue to evolve. The European Medicines Agency (EMA) updated its nitrosamine guidance in October 2025, while its acceptable intake information was updated again in June 2026.
"As the industry's understanding of nitrosamine risk continues to evolve, manufacturers are moving beyond broad risk assessments toward more product-specific decision-making," said Bart Pelgrims, Vice President, R&D, Lonza Capsugel.
"That shift requires not only reliable analytical data, but also the ability to interpret that data in the context of drug formulation, manufacturing processes and regulatory requirements."
By bringing these capabilities together, we help customers develop risk management strategies that are both scientifically robust and practical to implement at scale.
