Experienced Nitrosamine Impurity Testing
Nitrosamine Analysis
Nitrosamines encompass various subcategories depending on their origin, such as those specific to the active(s) in your drug product compared to others related to the processes used in production and formulation. Our expert team has developed screening methods for all seven nitrosamines specifically called out in FDA and UPS guidance. We offer validation of our method for your specific drug product and limits.
Small Molecule Nitrosamines
Related to the solvents and reagents used in manufacturing.
Nitrosamine Drug Substance Related Impurity (NDSRI)
Related specifically to the active(s) in your drug product.
Nitrite
Related to the excipient and solvent products used in the processes spanning synthesis, production, and formulation.
Nitrosamine Risk Assessment
Nitrosamine impurities in pharmaceuticals and other drug products are assessed
by our Organic Spectroscopy group with a range of methods and equipment.
Prepare your formulation with confidence by leveraging non-GMP screening to identify potential nitrosamine impurities. By characterizing the API and excipients early on, it affords the opportunity to consider chemicals of concern or processes that could compromise finished product safety and efficacy which could require reformulation during critical stages of advancement.
When product risk assessments identify potential nitrosamine impurities, regulators require validated, quantitative results to confirm any nitrosamines in the product are below the allowable intake (AI). If sponsors don’t supply results, regulators request this data during their review which could delay the approval process. Our team validates methods for such products to satisfy this requirement and avoid setbacks.
Testing and evaluations are conducted by experts with decades of experience in trace impurities analyses. When determining the approach, we carefully consider the materials and processes at play to deliver the most reliable results with required sensitivity.
The FDA establishes allowable nitrosamine limits which is subject to regular change, sometimes as often as every six months, as more studies and risk assessments are completed.
Our expert team has developed screening methods for all seven nitrosamines specifically called out in FDA and USP guidance. Partnering with our team ensures the latest standards are upheld so you can accurately gauge product and process compliance.
Integrated Laboratory Services
When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.