Melamine Analysis in Pharmaceutical Industry with SeQuant™ ZIC®-HILIC column from Merck
- Melamine in Pharma Raw Materials
FDA Issues Pharmaceutical Industry Guidance on Preventing Melamine Contamination
The U.S. Food and Drug Administration (FDA) issued recently a Guidance for Industry - Pharmaceutical Components at Risk for Melamine Contamination. It says that certain pharmaceutical ingredients used in the manufacture or preparation of drug products are recommended to be screened for melamine and triazine analogues like cyanuric acid.
Early this year the FDA published a method for detecting melamine and cyanuric acid in infant formula.
"The FDA urges implementation of appropriate controls to assure consumers that melamine contamination will not happen in the pharmaceutical supply chain," said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. "We look forward to working with industry on this serious public health concern."
At the moment, FDA has no reason to believe that pharmaceutical supplies are contaminated with melamine, but the recent contamination incidents involving pet and livestock food products in the United States, and milk products for infants in China, illustrate the potential for drug components to be contaminated with melamine.
Hence, it is important for drug manufacturers to assure that no component used in the manufacture of any drug is contaminated with melamine. FDA recommends that pharmacy compounders who use at-risk components in drugs ensure proper testing.
Requirements and recommendations
The guidance for pharmaceuticals recommends the use of FDA-published methods based on equipment generally available to pharmaceutical manufacturers or contract testing labs. The test method used should be suitable to assay melamine contamination down to at least 2.5 parts per million (ppm).
Recommended analysis methods are based on liquid chromatography triple quadruple tandem mass spectrometry (LC-MS/MS) or gas chromatography/mass spectrometry (GC-MS). The LC MS/MS method is based on Merck SeQuant™ ZIC®-HILIC HPLC separation and also urge the need to prevent melamine degradation during sample handling.
This list was based on the FDA Inactive Ingredient Database (IID), and is not considered to be exhaustive, and it is essential that manufacturers evaluate their drug components to determine whether they are vulnerable to melamine contamination.
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