Albumin Human
(al bue' min hue' man).
» 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. 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.
Packaging and storage— Preserve in tight containers, and store at the temperature recommended by the manufacturer or indicated on the label.
Expiration date— The expiration date is not later than 5 years after issue from manufacturer's cold storage (5, 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.
Labeling— Label it to state that it is not to be used if it is turbid and that it is to be used within 4 hours after the container is entered. Label it also to state the osmotic equivalent in terms of plasma, the sodium content, and the type of source material (venous plasma, placental plasma, or both) from which it was prepared. Label it also to indicate that additional fluids are needed when the 20-g per 100-mL or 25-g per 100-mL product is administered to a markedly dehydrated patient.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Fouad Atouf, Ph.D.
Senior Scientific Liaison
(BIO22010) Monographs - Biologics and Biotechnology 2
USP35–NF30 Page 2083
Pharmacopeial Forum: Volume No. 31(5) Page 1338