Catalent offers melamine testing service

Lactose powderCatalent Pharma Solutions has developed a set of tests for trace amounts of key contaminants, including melamine, in medicines and foods.

The new tests comply with the US Food and Drug Administration's recently-published guidance entitled Pharmaceutical Components at Risk for Melamine Contamination, which asks for melamine testing for all raw materials that contain more than 2.5 per cent nitrogen content and rely on a nitrogen test for identification.

Last year, around 300,000 children in China were poisoned by deliberately falsified milk and milk products containing melamine, with more than 290,000 falling ill, around 52,000 requiring hospitalisation, and at least six deaths.

"The current good manufacturing practice (CGMP) regulations require that all components (i.e. ingredients or raw materials) be tested before they are released for use in the manufacture or preparation of drug products," said Catalent in a statement.

"It is critical that all manufacturers determine whether they are using an at risk component for melamine contamination to manufacture or prepare a drug product."

Catalent says it has qualified a method for determining if suspect excipients are contamination-free to within 2.5 parts per million, and provide customers with validated limits tests for trace levels of four contaminants in lactose.

The gas chromatography-mass spectrometry (GC-MS) method is based on that provided by the FDA for the presence of melamine and three other contaminants, namely ammeline, ammelide, and cyanuric acid.

Melamine is a compound made of carbon, nitrogen and hydrogen and is typically combined with formaldehyde to produce a durable and mouldable plastic that is fire and heat resistant. Trace amounts of melamine have recently been discovered to be toxic to dogs, cats, pigs, and chickens by veterinary scientists after kidney or renal failure occurred due to their food being contaminated with the chemical.

"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," said Kent Payne, vice president and general manager of Catalent's respiratory, analytical and biotechnology services business.

 "Catalent can ... provide results within 48 hours from receipt of samples," he added.

Related articles:

FDA melamine guidance needs revision, says Hovione CEO

Spectrum will vet raw materials for melamine risk

FDA calls for melamine screening in pharmaceuticals

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