Albutein Description

Albumin (Human) U.S.P., Albutein Solution is a sterile, aqueous solution for single dose intravenous administration containing 5%, 20% and 25% human albumin (weight/volume). Albutein is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of albumin. Albutein 5% solution is osmotically and isotonically equivalent to an equal volume of normal human plasma. Albutein 20% is osmotically equivalent to four times its volume of normal human plasma. Albutein 25% is osmotically, equivalent to five times its volume of normal human plasma. Albutein contains 130-160 milliequivalents of sodium ion per liter and has a pH of 7.0 ± 0.3. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives.
Albutein is heated at 60°C for ten hours. No positive assertion can be made, that this heat treatment completely destroys the causative agents of viral hepatitis, however, there are no known confirmed cases of viral hepatitis which have resulted from the administration of Albutein.