Japanese minimum requirements for albumin preparations: recent amendments and current problems.

The following amendments have been introduced to the Minimum Requirements for Human Serum Albumin (HSA) and Plasma Protein Fraction (PPF): 1) The upper limit of sodium content was fixed at 3.7 mg/ml; 2) test for chloride content was introduced; 3) sodium and chloride contents were required to be stated on the label; 4) use of zone electrophoresis was introduced in addition to the free-boundary electrophoresis; and 5) albumin content in HSA was lowered from 97% to 96%. Moreover, current problems in quality control which may require further amendments were discussed, namely: 1) limulus amoebocyte lysate test to replace or supplement the pyrogen test in rabbits; 2) attempt of quantitative expression of visual turbidity; 3) establishment of reference A and B blood group substances; 4) gel permeation analysis and scanning at 370-800 nm; and 5) test for prekallikrein activator (PKA).