Contamination of Commercial Blood Products by Di‐2‐Ethylhexyl Phthalate and Mono‐2‐Ethylhexyl Phthalate1

Abstract

Blood fractionation products obtained from three different manufacturers were analyzed to determine if either mono‐2‐ethylhexyl phthalate (MEHP) or di‐2‐ethylhexyl phthalate (DEHP) were contaminants of any of the fractionated proteins. The only protein fraction to contain DEHP was factor IX (23μg/ml) from one company. However, MEHP was detected in low levels in several of the 5% normal serum albumin, 5% plasma protein fraction, factor VIII and factor IX samples. 25% normal serum albumin contained the highest level of MEHP with concentrations of up to 300 μg/ml (40% of the plasma level) depending on the sample. Attempts to remove MEHP using dialysis or ultrafiltration were unsuccessful and indicated a close association of the MEHP with albumin. There was a definite correlation between storage and transportation conditions and the level of MEHP in both plasma and 25% normal serum albumin. The highest levels of this phthalate acid ester were found in the products made from the plasma which had been shipped at ambient temperature. Contrary to published data, storage of plasma at ‐30°C for up to 6 months prevented the accumulation of MEHP.