The objective of this project is to develop methodology and validation data for some constituents of various injectable biological products including: (1) phenol used as a preservative in products such as allergenic extracts as a preservative and/or stabilizer, (3) pyridine used in the manufacture of certain allergenic extracts, (4) m-cresol used as an anti-microbial preservative in bacterial vaccines, (5) 2-phenoxyethanol used as a preservative in inactivated Polio Virus Vaccine, (6) formaldehyde used as an inactivating agent in Influenza Virus Vaccine, Hepatitis B Vaccine, etc., (7) chloride ion in albumin and (8) histamine in Histamine, Positive Skin Test Control. Gas chromatographic methods, incorporating internal standards have been developed for phenol, m-cresol and 2-phenoxyethanol. An HPLC method involving pre-column derivatization with p- nitrobenzylhydroxylamine (PNBA) has been developed for the determination of residual formaldehyde in viral vaccines and formaldehyde-modified allergenic extracts. HPLC methods for histamine are being evaluated, one involving pre-column derivatization with o-phthaldialdehyde and fluorescence detection, another involving ion-pair chromatography and low wavelength UV detection. Both methods allow the determination of low ppm levels of histamine in the allergenic product, Histamine, Positive, Skin Test Control. A study comparing and validating these two procedures in progress.

National Institute of Health (NIH)
Food and Drug Administration (FDA)
Intramural Research (Z01)
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