Ryhänen, J., Niemi, E.U.O.O., Serlo, W., Niemelä, E., Sandvik, P., Pernu, H. and Salo, T., 1997. Biocompatibility of nickel‐titanium shape memory metal and its corrosion behavior in human cell cultures. Journal of Biomedical Materials Research: An Official Journal of The Society for Biomaterials and The Japanese Society for Biomaterials, 35(4), pp.451-457.
It is a Class 2a elemental impurity according to ICH Q3D. It is an known immune system sensitiser
From ICH Q3D " Class 2A elements have relatively high probability of occurrence in the drug product and thus require risk assessment across all potential sources of elemental impurities and routes of administration (as indicated). The class 2A elements are: Co, Ni and V. "