The application of the endotoxin test for globulin and other blood products

The application of the endotoxin test for globulin and other blood products were investigated by two different limulus amebocyte lysate (LAL) test met hods, colorimetric and kinetic turbidimetric methods, using two endotoxin-s pecific reagents. By the dilution of the blood products in 40 times or more , spiked endotoxin in the products was recovered accurately showing neither inhibition nor enhancement. The definite difference was not shown between the results obtained by the two LAL test methods. According to the method o f the endotoxin test described under General Tests of The Japanese Pharmaco peia (thirteenth edition), JPXIII, the maximum valid dilution (MVD) for the se products will be calculated to be 40 or more, so it is capable to measur e the endotoxin limit for each product. This study indicates that the endot oxin test is applicable to measure the endotoxin content in globulin and ot her blood products as an alternative method for the rabbit pyrogen test.