»Plasma Protein Fraction conforms to the regulations of the federal Food and Drug Administration concerning biologics (640.90to 640.96)(see Biologics á1041ñ).It is a sterile preparation of serum albumin and globulin obtained by fractionating material (source blood,plasma,or serum)from healthy human donors,the source material being tested for the absence of hepatitis Bsurface antigen.It is made by a process that yields a product having protein components of approved composition and sedimentation coefficient content.Not less than 83percent of its total protein is albumin and not more than 17percent of its total protein consists of alpha and beta globulins.Not more than 1percent of its total protein has the electrophoretic properties of gamma globulin.It is a solution containing,in each 100mL,5g of protein,and it contains not less than 94percent and not more than 106percent of the labeled amount.It contains no added antimicrobial agent,but it contains sodium acetyltryptophanate with or without sodium caprylate as a stabilizing agent.It has a sodium content of not less than 130mEq per liter and not more than 160mEq per liter and a potassium content of not more than 2mEq per liter.It has a pHbetween 6.7and 7.3,measured in a solution diluted to contain 1percent of protein with 0.15Msodium chloride.It meets the requirements of the test for heat stability.