The objectives 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 and Tuberculin PPD, (2) 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 is in progress.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Intramural Research (Z01)
Project #
1Z01BB001009-14
Application #
3792391
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
14
Fiscal Year
1992
Total Cost
Indirect Cost