DEFINITION

Albumin Human conforms to the regulations of the federal Food and Drug Administration concerning biologics (640.80 to 640.86) (see Biologics 〈1041〉). It is a sterile, nonpyrogenic preparation of serum albumin obtained by fractionating material (source blood, plasma, serum, or placentas) 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 that is safe for intravenous use. NLT 96% of its total protein is albumin. It is a solution containing, in each 100 mL, either 25 g of serum albumin osmotically equivalent to 500 mL of normal human plasma, or 20 g equivalent to 400 mL, or 5 g equivalent to 100 mL, or 4 g equivalent to 80 mL, and contains NLT 93.75% and NMT 106.25% of the labeled amount in the case of the solution containing 4 g in each 100 mL, and NLT 94.0% and NMT 106.0% of the labeled amount in the other cases. It contains no added antimicrobial agent, but may contain 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. It has a heme content such that the absorbance of a solution, diluted to contain 1% of protein, in a 1-cm holding cell, measured at a wavelength of 403 nm, is NMT 0.25. It meets the requirements of the test for heat stability and for pH.