Melamine has been in the headlines since last September when it was linked to three deaths and a number of cases of acute kidney failure in children who had consumed milk products thought to be contaminated with the chemical.
Although investigations are ongoing, the speculation is that the nitrogen-rich chemical had been added to milk products sourced in China in a fraudulent effort to boost protein content as current tests are based on the detection of nitrogen.
The US Food and Drug Administration’s (FDA) initial focus was on detecting melamine in foods as the levels likely to be contained in such products were deemed to be more of a risk to public health.
Subsequent research suggested that even trace amounts of the chemical are harmful prompting the FDA, in August, to issue guidance entitled “Pharmaceutical Components at Risk for Melamine Contamination.”
At the time the agency explained that, although an “appropriate level” has not been established, risk assessments used to test foods do “not fully address the risks applicable to drugs.”
The FDA also said that, while it was not aware of any melamine contaminated drugs, a wide range of milk-derived components are used in pharmaceuticals, particularly as excipients, and these may pose a potential risk.
The agency’s guidance lists albumin, sodium caseinate, gelatine and lactose among those most likely to be affected by any contamination based on a search of the US Pharmacopoeia.
The full guidance can be accessed here.
Catalent’s new assay offering is designed to help manufacturers meet the new FDA guidelines and can qualify drug excipients as being free of the toxic chemical to within 2.5 parts per million.
The firm said that the validated assay can also detect ammeline, ammelide, and cyanuric acid in lactose, which is one of the most commonly-used milk-derived products in the pharmaceutical sector.
Kent Payne, Catlent’s VP of respiratory, analytical and biotechnology services, said: “Detecting trace levels of melamine in food and medicinal products at these levels is a challenging process, but is key to help avoid future public health crises.
He added that: “In order to support this critical public health need, Catalent can expedite this testing and provide results within 48 hours from receipt of samples.”
The assay is described here.