Analysis of commercial albumin (ALB) preparations for mono-2-ethylhexyl phthalate (MEHP) and di-2-ethylhexyl phthalate (DEHP)

Over a 2 year period, 85 lots of human albumin (ALE) from various manufacturers were analyzed for levels of mono-2-ethylhexyl phthalate (MEHP) and di-2-ethylhexyl phthalate (DEHP) using high performance liquid chromatography (HPLC). For 29 lots initially surveyed, levels of DEHP and derivatized MEHP were assessed independently using capillary gas chromatography-mass spectrometry (CC-MS) analysis. High (6-8 mu g/mL) to very high (20 mu g/mL) levels of MEHP were found only in samples arising from ion exchange chromatography (IEC) processing compared to the much lower MEHP levels found in cold ethanol fractionation (CDF) processed ALE. DEHP levels appeared uniformly low in all samples regardless of method of ALB preparation Assay results are also reported and discussed for ALB samples taken at different production stages, from fresh and frozen plasma and for a mixed batch of liquid, paste and solid in-process ALE samples. The higher levels of MEHP in ion exchange ALE were found to correlate directly to the use of stored plasma as the source material.