Nitrosamines are a group of chemical compounds that can be found in various products, including pharmaceuticals. They have become a significant concern within the pharmaceutical industry due to their potential carcinogenic properties. Nitrosamines can form as impurities in drug substances during manufacturing processes, particularly when certain amine-containing compounds react with nitrites under specific conditions. In addition, Nitrosamine Drug Substance-Related Impurities (NDSRIs) can form in drug products due to the trace presence of nitrates and nitrites in most excipients which act as nitrosating agents during formulation or over time.
The Carcinogenic Potency Categorization Approach (CPCA) is utilized to determine Acceptable Intake (AI) limits for NDSRIs. The CPCA methodology is based on structure-activity relationships and considers specific structural features to define potency levels. Reference standards play a vital role in this process by providing a basis for comparison and evaluation, aiding in the accurate identification and quantification of impurities like NDSRIs present in drug substances or products. This infographic details the features and benefits of selecting appropriate NDSRI reference samples. Download now to learn more.
