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US FDA recommends melamine testing in the pharmaceutical components

US FDA in August 2009 published a guidance for industry titled Pharmaceutical Components at Risk for Melamine Contamination after it received reports of food products in China been contaminated with melamine, leading to thousands of hospitalizations and at least three deaths by September 2008. Though still the time there had been no reports of pharmaceutical products or ingredients having been contaminated, the guidance was proactively published to help manufacturers of pharmaceutical ingredients and products, control the components that are at risk of being contaminated.

Melamine was added to food products intended to contain protein to increase the apparent protein content. When samples were tested for protein based on total nitrogen method, it could not be distinguished from proteins and being a nitrogen-rich molecule gave higher values of protein content. Melamine contamination only came to the forefront after numerous adverse health events including death were reported after consumption of contaminated products.

The guidance document recommends the use of an LCMSMS or GC MS method to test for Melamine and Triazine Analogs. Our laboratory has established the LCMSMS method and is routinely carrying out analysis for detection of melamine in various pharmaceutical products and ingredients. This problem is also USP hot topic and USP is collaborating with US FDA to further develop methods for testing it in pharmaceutical products and ingredients.

Given below is the list of at-risk components published by the US FDA  as part of the guidance for industry, for these it is essential that manufacturers evaluate their drug components to determine whether they are vulnerable to contamination.

  • Adenine (USP)
  • Albumin (IID)
  • Amino acids derived from casein protein hydrolysates
  • Ammonium Salts
  • Calcium pantothenate (USP)
  • Caseinate or sodium caseinate (IID)
  • Chlorophyllin copper complex sodium (USP)
  • Colloidal oatmeal (USP)
  • Copovidone (USP/NF)
  • Crospovidone (USP/NF)
  • Dihydroxyaluminum aminoacetate (USP)
  • Gelatin (IID)
  • Glucagon (USP)
  • Guar gum (USP/NF)
  • Hyaluronidase (USP)
  • Imidurea (USP/NF)
  • Lactose (USP/NF, IID)
  • Melphalan (USP)
  • Povidone (USP/NF)
  • Povidone-Iodine (USP)
  • Protamine sulfate (USP)
  • Protein hydrolysate (powder) for injection (USP)
  • Taurine (USP)
  • Thioguanine (USP)
  • Urea (USP)
  • Wheat bran (USP)
  • Zein (USP/NF)

Arbro conducts melamine testing in a wide range of pharmaceutical ingredients, food products, agricultural products, raw materials and food ingredients. Our clients are assured with rapid turn around, economical pricing and the highest level of confidence in the results.

Contact us today for testing of your products and ingredients for contamination with melamine.

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