A modified method for the determination of aluminium-gel in vaccine.
The conventional method of aluminium analysis, described in the Biological Preparation Standard for Animals, was found to give erroneous results in the case of vaccine containing aluminium-gel as an adjuvant. This is because of incomplete decomposition of the gel and unsettled reaction system for the determination. But these problems were settled definitely. Heating on a direct fire for 15 min, by which temperature of the content attained 115-120 degrees C at atmospheric pressure, allowed the gel to complete decomposition and the result came to close the theoretical value. And a constant result by the decomposition itself was obtained with 2 volumes of nitric acid against 1 volume indicated in the standard method. Quantitative reaction of the gel-decomposed solution did hold in range of about 0.75-2.0 micrograms aluminium per ml. Use of acetate buffer solution for dilution of the decomposed solution following by sampling in 2 volumes of the dilution into the reaction mixture made the variation to the least as compared with the water-dilution following by 1 volume sampling indicated in the standard method. By these modified conditions, we succeeded in reducing the relative error and the coefficient of variation to less than +/- 5% and +/- 2% respectively.
Doi
M
M
Kuramoto
H
H
Hasegawa
S
S
Tanaka
Y
Y
Fujisaki
Y
Y
D000276:Adjuvants, Immunologic / Q000032:analysis*; D000535:Aluminum / Q000032:analysis*; D017607:Aluminum Compounds; D000536:Aluminum Hydroxide / Q000032:analysis*; D003124:Colorimetry / Q000379:methods*; D005782:Gels; D006358:Hot Temperature; D010710:Phosphates / Q000032:analysis*; D014612:Vaccines / Q000032:analysis*
D000276:Adjuvants, Immunologic; D017607:Aluminum Compounds; D005782:Gels; D010710:Phosphates; D014612:Vaccines; D000536:Aluminum Hydroxide; D000535:Aluminum; C012714:aluminum phosphate