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).
D001798:Blood Proteins / Q000592:standards; D002712:Chlorides / Q000592:standards; D006801:Humans; D007564:Japan; D008722:Methods; D010952:Plasma Substitutes / Q000592:standards*; D011356:Product Labeling; D011786:Quality Control; D012709:Serum Albumin / Q000592:standards*; D000075462:Serum Albumin, Human; D012712:Serum Globulins; D012964:Sodium / Q000592:standards
D001798:Blood Proteins; D002712:Chlorides; D010952:Plasma Substitutes; D012709:Serum Albumin; D012712:Serum Globulins; C008930:plasma protein fraction; D012964:Sodium; D000075462:Serum Albumin, Human