Nitrosamine impurities have become an important pharmaceutical quality and regulatory concern worldwide.
PharmaPrimes provides comprehensive scientific and analytical services to support pharmaceutical companies in assessing, investigating, testing, and controlling conventional nitrosamines and Nitrosamine Drug Substance-Related Impurities (NDSRIs).
Systematic evaluation of potential nitrosamine formation in drug substances and drug products.
Relevant risk factors may include:
Development and validation of sensitive analytical methods using LC-MS/MS and GC-MS/MS.
Method selection and sensitivity are tailored to the chemical characteristics of the target nitrosamine, the pharmaceutical matrix, and the required acceptance limit.
Scientific investigation of nitrosamine formation associated with:
We support scientifically justified control and mitigation strategies based on identified risks.
Comprehensive testing of APIs, raw materials, finished products, and stability samples, including impurity analysis, dissolution, elemental impurities, residual solvents, Extractables & Leachables, physical testing, and analytical method development.
Scientific and regulatory support including pharmaceutical dossier assessment, CTD documentation support, scientific justification, and regulatory submission support.
Formulation development, process development and optimization, analytical method development and validation, stability studies, regulatory documentation support, and pharmaceutical dossier assessment.
From risk assessment to confirmatory testing and root-cause investigation, our scientists can support your nitrosamine compliance strategy.
