Following high-profile incidents of melamine contamination the US Food and Drug Administration (FDA) recommended that pharma tests at-risk materials. This has prompted service providers, such as Catalent and Metrics, to add melamine testing services to their offerings.
Metrics' test uses a high-performance liquid chromatography (HPLC) separation method with UV detection to identify the presence of melamine down to the FDA recommended limit of 2.5 parts per million.
Furthermore, Metrics evaluates matrix interfaces on each sample tested and confirmed to boost reliability. Jack Pender, senior scientist at Metrics, explained that the method is designed to be “simple in principle and easily adaptable to additional sample matrices as needed”.
Pender added that requests for melamine testing of gelatine capsule shells have been most common. These are derived from animal collagen and have a wide range of possible colour combinations.
“The presence of various colouring agents means each gelatine capsule represents a different challenge for identifying and quantifying melamine at trace levels”, explained Pender, adding that Metrics’ test “easily adapts to those differences”.
Melamine has been added to products to increase apparent protein content. When melamine and cyanuric acid, a similar compound, are together in the body they can cause kidney failure.
Pended explained that “there is no legitimate reason why melamine should be present in any pharmaceutical product”. He added that melamine’s potential toxicity means it is “critical that companies accurately test at-risk start materials before they manufacture drug or food products”.
Protein content is typically gauged by testing for nitrogen. However, melamine is nitrogen-based, meaning contamination goes unnoticed unless a specific test is implemented.