The objectives of this project are to develop and validate methodologies for chemical constituents of biological products whose concentration is vital to product stability, efficacy or safety. These include: (1) phenol used as an antimicrobial preservative in multi-use parenterals such as allergenic extracts and bacterial vaccines, (2) glycerin used in allergenic extracts and thrombin as a preservative and/or stabilizer, (3) 2-phenoxyethanol used as a preservative in inactivated Poliovirus Vaccine and combined bacterial vaccines, (4) glutaraldehyde used as inactivating or conjugating agent in vaccines, (5) formaldehyde used as an inactivating agent in Influenza Virus Vaccine, Hepatitis B Vaccine, etc., (6) chloride in Human Serum Albumin and dextran volume expanders, (7) histamine in Histamine, Positive Skin Test Control, (8) residual tetrachloroethylene in pollen allergenic extracts, (9) organic, natural product and complex mixture components of allergen patch tests, (10) glutamate decarboxylase and tyrosine hydroxylase to be used as determinant for TSE (Transmissible Spongiform Encephalopathy) agents.
