International – Drugmakers should question suppliers’ nitrosamine tests

The pharmaceutical industry needs to closely evaluate suppliers’ testing to ensure that accurate methods are being used to assess nitrosamine risks in drug products. Not questioning dubious results can wreak havoc and unnecessarily flag high levels of impurities where none may exist, warned an official from Perrigo at a 31 August webinar.

The focus of the webinar, convened by the International Pharmaceutical Excipients Council (IPEC), focused on a set of best practices for assessing and detecting nitrosamines and how to work with suppliers in testing products for these potentially carcinogenic compounds while complying with FDA’s guidance calling for such testing, (RELATED: N-Nitrosamine impurities: FDA issues detection, prevention strategies Regulatory Focus, 1 September 2020)

Active pharmaceutical ingredients (APIs) as well as excipients need to be tested as they may contain nitrite and nitrosamine impurities, according to the guidance, which was prompted by a series of recalls that beginning in 2019 for blood pressure medicines which contained a high level of nitrosamine impurities…