Catalent expands melamine-testing capabilities
Catalent Pharma Solutions has developed new FDA guidance-compliant tests for trace amounts of key contaminants in food and medicine. Incidents of melamine contamination in milk products, baby formula, dairy and non-dairy products manufactured in China have been widely reported, leading to product recalls and increased inspections by the FDA.
Catalent Pharma Solutions has developed new FDA guidance-compliant tests for trace amounts of key contaminants in food and medicine. Incidents of melamine contamination in milk products, baby formula, dairy and non-dairy products manufactured in China have been widely reported, leading to product recalls and increased inspections by the FDA.
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 (21 CFR 211.84). 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.
In response to the FDA's new guidance, Pharmaceutical Components at Risk for Melamine Contamination, Catalent has successfully qualified a method for determining if suspect excipients are contamination-free to within 2.5 parts per million. The method is based on that provided by the FDA (Laboratory Information Bulletin No. 4423 GC-MS Screen for the Presence of Melamine, Ammeline, Ammelide, and Cyanuric Acid).
Catalent is now able to provide customers with validated limits tests for trace levels of melamine, ammeline, ammelide, and cyanuric acid in lactose.
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, vp and general manager of Catalent's respiratory, analytical and biotechnology services business. "Catalent can expedite this testing and provide results within 48 hours from receipt of samples."