Way back in January, I did a post on Melamine testing stemming from the new FDA guidance document that appeared around that time. Since then, test labs like Catalent and Metrics have stepped up to provide melamine testing services. Metrics indicates it uses the approved HPLC method to identify melamine contamination down to the FDA's recommended sensitivity level of 2.5 ppm.
To date, Metrics indicates that customers are testing predominantly gelatine capsules - derived from animal collagen. The different coloring agents used in capsules does present some challenges in testing when you need to get to the 2.5 ppm level, but this is readily achievable.
Melamine testing is primarily necessary in those instances when the product or raw material has only been subjected to a total nitrogen test without any other form of testing for purity. In the above post, you can examine the SAFC risk based assessment toward melamine testing.
Posted by Bruce Lehr March 31st 2010.
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