The Role of Excipients in Determining N-Nitrosamine Risks for Drug Products

IPEC (International Pharmaceutical Excipients Council Federation) published a summary position paper on “The Role of Excipients in Determining N-Nitrosamine Risks for Drug Products”. This 7-page position paper explains IPEC Federation‘s perspective on N-nitrosamine risk assessments.

IPEC states that the issue for the paper is the presence of N-nitrosamines in drug products continues to be a global concern. Excipients are considered as a potential risk factor during the drug product risk assessment. It is the purpose of this position paper to elaborate on the potential contribution that excipients may or may not have to nitrosamine formation in final drug products. Also considered are the presence of nitrites and vulnerable amines in the excipients.

Even though excipient manufacturers are not required to provide risk assessments on nitrosamines to regulatory agencies, the IPEC encourages a partnership between pharmaceutical manufacturers and excipient suppliers based on risk. Excipient manufacturers have a stake in providing safe excipients. A variety of water quality, raw material origins, and excipient processing conditions can contribute to the formation of nitrites and nitrates. Potential risks associated with excipients should be carefully evaluated by excipient suppliers. In this way, medicinal product manufacturers will be able to fulfill their regulatory obligations, which are to conduct risk assessments for their drugs.

Download the full 7 page IPEC position paper