Plasma Protein Fraction
»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.
Packaging and storage— Preserve at the temperature indicated on the label.
Expiration date— The minimum expiration date is not later than 5years after issue from manufacturer's cold storage (5,1year)if labeling recommends storage between 2and 10;not later than 3years after issue from manufacturer's cold storage (5,1year)if labeling recommends storage at temperatures not higher than 30.
Labeling— Label it to state that it is not to be used if it is turbid and that it is to be used within 4hours after the container is entered.Label it also to state the osmotic equivalent in terms of plasma and the sodium content.
Auxiliary Information— Staff Liaison:Radhakrishna S Tirumalai,Scientist
Expert Committee:(BBP)Blood and Blood Products
USP28–NF23Page 1570
Phone Number:1-301-816-8339