Title : Setting Limits for Complex Nitrosamines
Nitrosamine impurities have been in the center of the stage of impurities in drug products for the past 3 years. Regulators and industry have been deliberating the methods for determining limits for this special class of mutagenic/carcinogenic impurities. Preliminary guidelines have been published by regulatory agencies, however, they lack guidance on how to set limits for API-related nitrosamines, also known as “Complex Nitrosamines”. My presentation will discuss the ongoing activities to come to a consensus between the regulatory agencies and the pharmaceutical industry on what is the adequate process to set acceptable intake limits for the complex nitrosamines.