Comparison of Karl Fischer titrimetric and gravimetric methods for determination of moisture content in BCG vaccine.
A model 447 Coulomatic K-F titrimeter was used to determine the water content of seventeen lots of freeze-dried Tice-substrain BCG vaccine. The results were compared with corresponding moisture contents determined by a standard gravimetric method at the time of manufacture. The advantages of the titrimetric method include simplicity, rapidity, convenience, sensitivity, reproducibility and specificity, whereas the gravimetric method is tedious and time-consuming. Although moisture content determined by the K-F titrimeter tended to be higher than that determined by the gravimetric method, the results correlated significantly (r = 0.882, P less than 10(-5]. Alteration of national and international regulations to permit use of the K-F titrimeter is recommended.
Department of Pharmaceutics, College of Pharmacy, University of Illinois, Chicago 60612.
M
M
Shi
M E
ME
Klegerman
M J
MJ
Groves
D001500:BCG Vaccine / Q000032:analysis*; D008722:Methods; D014867:Water / Q000032:analysis*
D001500:BCG Vaccine; D014867:Water