DEFINITION

Plasma Protein Fraction conforms to the regulations of the US Food and Drug Administration (FDA) concerning biologics (21 CFR § 640.90–640.96) (see Biologics 〈1041〉 for additional information). 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 B surface antigen. It is made by a process that yields a product having protein components of approved composition and sedimentation coefficient content. NLT 83% of its total protein is albumin, and NMT 17% of its total protein consists of alpha and beta globulins. NMT 1% of its total protein has the electrophoretic properties of gamma globulin. It is a solution containing, in each 100 mL, 5 g of protein, and it contains NLT 94% and NMT 106% 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 NLT 130 mEq/L and NMT 160 mEq/L and a potassium content of NMT 2 mEq/L. It has a pH between 6.7 and 7.3, measured in a solution diluted to contain 1% of protein with 0.15 M sodium chloride. It meets the requirements of the test for heat stability.