Melamine Testing

In August 2009, the US FDA issued its Industry Guidance on preventing melamine contamination in pharmaceutical products. In this white paper, the FDA states that certain pharmaceutical ingredients used in the manufacture or preparation of drug products should be tested for melamine.

Maxxam has been offering melamine testing in food ingredients and additives since the initial issues with melamine laced pet foods and infant formula products surfaced. The laboratory now offers melamine testing for clients in the pharmaceuticals market who face the possibility of working with at-risk components.

As per the FDA’s guidance, Maxxam Ltd. is equipped with GCMS and LCMS/MS instrumentation to meet all the necessary detection limits associated with melamine testing. The FDA recommended limit of detection for melamine in pharmaceuticals is 2.5 ppm and as low as 0.25 ppm for food and food-related products.

GC-MS: 2.5ppm
LC-MS-MS: 0.25ppm

The FDA considers “at-risk components” to be those ingredients or raw materials that rely on a test for nitrogen content for their identity, purity, or strength and that contain nitrogen in amounts greater than 2.5%. Below is a short list of those components that should be tested for possible presence of melamine:

  • Adenine
  • Albumin
  • Ammonium salts
  • Caseinate
  • Copovidone
  • Crospovidone
  • Gelatin
  • Glucagon
  • Hyaluronidase
  • Imidurea
  • Lactose
  • Melphalan
  • Povidone
  • Povidone-Iodine
  • Protamine sulfate
  • Taurine

By

Donna Garbutt, M.B.A. Chief Executive Officer Maxxam is the Canadian market leader in analytical services and solutions to the energy, environmental, food and DNA industries and a member of the Bureau Veritas Group of companies – a world leader in testing, inspection and certification services. We support critical decisions made by our customers through the application of rigorous science and the knowledge and expertise of our over 2200 employees. Our annual Corporate Responsibility Report outlines our efforts to continually improve our business performance and practices. Its publication is an industry first and an integral part of our commitment to success with responsibility. LinkedIn
Maxxam Analytics Maxxam is the Canadian market leader in analytical services and solutions to the energy, environmental, food and DNA industries and a member of the Bureau Veritas Group of companies – a world leader in testing, inspection and certification services. We support critical decisions made by our customers through the application of rigorous science and the knowledge and expertise of our over 2200 employees. Our annual Corporate Responsibility Report outlines our efforts to continually improve our business performance and practices. Its publication is an industry first and an integral part of our commitment to success with responsibility.
500 – 1919 Minnesota Ct., Mississauga, Ontario L5N 0C9
Phone: (905) 288-2150