Pharmaceutical manufacturers evaluating potential nitrosamine formation in drug products can now access nitrite testing and related scientific and regulatory support through a new integrated service from Lonza Capsugel.

The offering is designed to help manufacturers investigate nitrite contributions from empty capsules and incorporate capsule-specific data into broader, product-level nitrosamine risk assessments. The service combines analytical testing with scientific interpretation and regulatory support, giving customers a single point of contact for investigations that may otherwise require multiple technical resources.

Nitrites present in an empty capsule can be a potential contributor to nitrosamine formation under certain drug product conditions. Consequently, understanding the nitrite profile of the capsule, together with the formulation and manufacturing process, can be an important component of a product-specific risk assessment.

Lonza Capsugel’s service provides manufacturers with nitrite testing supported by a validated analytical method, along with data interpretation and technical consultation. Depending on the requirements of an individual project, the offering can also include documentation for regulatory submissions, risk investigations, collaborative studies, and scientific support for interactions with regulatory authorities.

A central component of the service is a nitrite quantification method developed specifically for the gelatin capsule matrix. The analytical procedure uses ion chromatography combined with Griess derivatization and has been validated in accordance with the principles of ICH Q2(R2).

The method is capable of quantifying nitrite concentrations down to 100 ppb. Its development addresses analytical considerations associated with the capsule matrix, including extraction, selectivity, and potential sources of interference.

This capability can be applied to routine capsule testing as well as comparative assessments and customer-specific investigations. The resulting analytical data can then be evaluated alongside information on the drug formulation and manufacturing process to support a more targeted assessment of potential nitrosamine risks.

“As the industry’s understanding of nitrosamine risk continues to evolve, manufacturers are moving beyond broad risk assessments toward more product-specific decision-making,” says 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.”

Nitrosamine risk assessment has become an important consideration for pharmaceutical manufacturers and marketing authorization holders as regulatory authorities worldwide continue to require the evaluation and mitigation of potential nitrosamine impurities.

For individual nitrosamine impurities, acceptable daily intake limits can be translated into product-specific concentration limits intended to protect patients. Depending on the composition and characteristics of a drug product, risk-management measures may also include establishing limits for nitrite levels in excipients and other formulation components.

For manufacturers, this creates a need to understand the potential contribution of individual raw materials and components within the context of the complete drug product rather than treating each material in isolation.

Lonza Capsugel’s integrated offering is intended to address this need by connecting capsule-specific analytical results with scientific expertise in capsules, formulations, and drug product development. Customers can use the resulting information to investigate potential sources of nitrite, assess their relevance to a specific product, and develop an appropriate risk-management strategy. The service also provides support for the documentation and scientific evaluation that may be required as part of regulatory interactions or submissions.

The new offering expands Lonza Capsugel’s existing scientific and technical services for pharmaceutical manufacturers. By combining analytical testing with interpretation and regulatory support, the company aims to provide a more integrated route for customers conducting product-specific nitrosamine evaluations. The approach is intended to help manufacturers generate the analytical evidence needed for their assessments while connecting that information to formulation, manufacturing, and regulatory considerations.

For more information, visit www.capsugel.com.