Catalent expands capabilities in testing for melamine in food and medicinal products
At a time when melamine-contamination has received global attention, Catalent Pharma Solutions continues to rapidly develope 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 titled “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 its customers successfully qualified and validated limits tests for trace levels of melamine, ammeline, ammelide, and cyanuric acid in lactose.
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