FDA recommends using a method demonstrated to be suitable for detecting melamine adulteration based on the manufacturer’s risk assessment and prevention strategy. The manufacturer’s selection of a sampling approach and test method sensitivity should address the possibility that 1) melamine might not be uniformly distributed in an at-risk component, or 2) that the source of intentional melamine contamination might be the starting material used to produce the at-risk component. The guidance provides a web-link to assay methods capable of detecting melamine at levels as low as 2.5ppm. These methods can detect melamine and cyanuric acid in complex matrices (protein materials) and, therefore, may be useful in developing test methods for other at-risk drug components. FDA also recognizes that a less sensitive method might also be appropriate for screening in certain cases.
