The objectives of this project are to develop and validate methodologies for the determination of trace metals in injectable biological products. This includes trace metals present as residuals of the manufacturing procedure, those present as impurities and those that are chemical constituents of biological products whose concentration is vital to product stability, efficacy or safety. Methodology used includes atomic absorption spectrometry, inductively coupled argon plasma emission spectrometry, inductively coupled argon plasma mass spectometry and ion chromatography. An interagency agreement with NIST resulted in data which gives the trace metal profile for a number of biological products. This survey identified high levels of aluminum in several albumins from one manufacturer. Toxicologists at FDA evaluated the data collected. A new objective involves evaluating the trace metal leachates from several types of glass vials including vials lined with silican dioxide coatings and glass vials fabricated with cerium. An ICP method has been developed for phosphorus in Haemphilus b Conjugate Vaccine. Work has been done on the determination of low levels of copper in Mega 1 and Mega 2 international standards for Antihemophilic Factor.
