|
|
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. Not less than 96 percent 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 thereof, and contains not less than 93.75 percent and not more than 106.25 percent of the labeled amount in the case of the solution containing 4 g in each 100 mL, and not less than 94.0 percent and not more than 106.0 percent 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 not less than 130 mEq per L and not more than 160 mEq per L. It has a heme content such that the absorbance of a solution, diluted to contain 1 percent of protein, in a 1-cm holding cell, measured at a wavelength of 403 nm, is not more than 0.25. It meets the requirements of the test for heat stability and for pH.
, 3 years) if labeling recommends storage between 2 and 10; not later than 3 years after issue from manufacturer's cold storage (5, 3 years) if labeling recommends storage at temperatures not higher than 37; and not later than 10 years after date of manufacture if in a hermetically sealed metal container and labeling recommends storage between 2 and 10.
467:
meets the requirements.