Lonza Capsugel has introduced a service to help drugmakers measure nitrite in empty gelatin capsules and assess whether it could contribute to nitrosamine formation in finished medicines.
The offering combines laboratory testing with data interpretation, scientific consultation and documentation for regulatory submissions, the company said Sept. 24. It also includes support for product-specific risk investigations and collaborative studies involving regulators.
Nitrites in capsule materials can contribute to the formation of nitrosamine impurities under certain conditions. Drugmakers must assess potential nitrosamine risks in their products and take steps to limit exposure where necessary. A product’s formulation and manufacturing process can affect that assessment.
Lonza said its analytical method was developed specifically for gelatin capsules. It combines ion chromatography with Griess derivatization and can quantify nitrite concentrations as low as 100 parts per billion. The company said it validated the method in line with ICH Q2(R2) principles, which address the validation of analytical procedures.
The testing can be used to compare nitrite levels across capsules and support investigations tailored to a manufacturer’s product. Lonza said its staff will help customers interpret results alongside formulation details, manufacturing processes and applicable regulatory requirements.
Regulators set acceptable daily intake limits for individual nitrosamine impurities, which manufacturers use to establish concentration limits for specific products. Depending on a medicine’s composition, controlling nitrite levels in ingredients or other components may be part of its risk-management approach.
Bart Pelgrims, Lonza Capsugel’s vice president of research and development, said manufacturers increasingly need product-specific evidence rather than broad risk assessments.