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 manu facturers were analyzed for levels of mono-2-ethylhexyl phthalate (MEH P) 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 c hromatography-mass spectrometry (CC-MS) analysis. High (6-8 mu g/mL) t o very high (20 mu g/mL) levels of MEHP were found only in samples ari sing from ion exchange chromatography (IEC) processing compared to the much lower MEHP levels found in cold ethanol fractionation (CDF) proc essed ALE. DEHP levels appeared uniformly low in all samples regardles s of method of ALB preparation Assay results are also reported and dis cussed for ALB samples taken at different production stages, from fres h and frozen plasma and for a mixed batch of liquid, paste and solid i n-process ALE samples. The higher levels of MEHP in ion exchange ALE w ere found to correlate directly to the use of stored plasma as the sou rce material.