CENTER FOR DRUG EVALUATION AND RESEARCH

DIVISION of
DRUG INFORMATION

Your source for the latest drug information. Know the moment it happens.

​

Spotlight on CDER Science Explores Approaches to Mitigate Nitrosamine Formation

In this Spotlight on CDER Science, CDER researchers conducted a study to evaluate pH adjustment and addition of antioxidants in tablet formulations using bumetanide (BMT) as a model drug product to mitigate the formation of N-nitrosobumetanide (NBMT).

NBMT is a known nitrosamine drug substance-related impurity (NDSRI) that may form in BMT. Two approaches previously recommended by CDER to mitigate small-molecule nitrosamine formation in drug products during formulation include the use of antioxidants (inhibitors) or increasing the pH of the product formulation. But limited research on these control strategies exists for NDSRIs.

This research helped support CDER’s Control of Nitrosamine Impurities in Human Drugs guidance by providing manufacturers with potential approaches to drug formulation to mitigate or prevent formation of NDSRIs in solid state (tablet) drug products. 

This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov.