Melamine Analysis in Pharmaceutical Industry with SeQuant^TM ZIC^®-HILIC columns from Merck

A Guidance for Industry – Pharmaceutical Components at Risk for Melamine Contamination has been issued by the U.S. Food and Drug Administration (FDA). 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.

The FDA chose the SeQuant™ ZIC^®-HILIC column as the best suited to sensitive and efficient detection of melamine contamination and consulted SeQuant scientists during method development. The resulting FDA-published method enables detection of melamine contamination to levels as low as 2.5 parts per million (ppm).

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.

The following list, based on the FDA Inactive Ingredient Database (IID), is not considered to be exhaustive.

The compounds at risk may be, but are not limited to:

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

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 which can be performed best with SeQant™ ZIC^®-HILIC columns.