In August 2009, the US FDA issued its Industry Guidance on preventing melamine contamination in pharmaceutical products. In this white paper, the FDA states that certain pharmaceutical ingredients used in the manufacture or preparation of drug products should be tested for melamine.
Maxxam has been offering melamine testing in food ingredients and additives since the initial issues with melamine laced pet foods and infant formula products surfaced. The laboratory now offers melamine testing for clients in the pharmaceuticals market who face the possibility of working with at-risk components.
As per the FDA’s guidance, Maxxam Ltd. is equipped with GCMS and LCMS/MS instrumentation to meet all the necessary detection limits associated with melamine testing. The FDA recommended limit of detection for melamine in pharmaceuticals is 2.5 ppm and as low as 0.25 ppm for food and food-related products.
The FDA considers “at-risk components” to be those ingredients or raw materials that rely on a test for nitrogen content for their identity, purity, or strength and that contain nitrogen in amounts greater than 2.5%. Below is a short list of those components that should be tested for possible presence of melamine:
- Ammonium salts
- Protamine sulfate