Albumin Human
»Albumin Human conforms to the regulations of the federal Food and Drug Administration concerning biologics (640.80to 640.86)(see Biologicsá1041ñ).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 Bsurface antigen.It is made by a process that yields a product that is safe for intravenous use.Not less than 96percent of its total protein is albumin.It is a solution containing,in each 100mL,either 25g of serum albumin osmotically equivalent to 500mLof normal human plasma,or 20g equivalent to 400mL,or 5g equivalent to 100mL,or 4g equivalent to 80mLthereof,and contains not less than 93.75percent and not more than 106.25percent of the labeled amount in the case of the solution containing 4g in each 100mL,and not less than 94.0percent and not more than 106.0percent 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 130mEq per Land not more than 160mEq per liter.It has a heme content such that the absorbance of a solution,diluted to contain 1percent of protein,in a 1-cm holding cell,measured at a wavelength of 403nm,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 5years after issue from manufacturer's cold storage (5
,3years)if labeling recommends storage between 2and 10;not later than 3years after issue from manufacturer's cold storage (5,3years)if labeling recommends storage at temperatures not higher than 37;and not later than 10years after date of manufacture if in a hermetically sealed metal container and labeling recommends storage between 2and 10.
,3years)if labeling recommends storage between 2and 10;not later than 3years after issue from manufacturer's cold storage (5,3years)if labeling recommends storage at temperatures not higher than 37;and not later than 10years after date of manufacture if in a hermetically sealed metal container and labeling recommends storage between 2and 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 4hours 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-mLor 25-g per 100-mLproduct is administered to a markedly dehydrated patient.
Auxiliary Information—
Staff Liaison:Radhakrishna S Tirumalai,Scientist
Expert Committee:(BBP)Blood and Blood Products
USP28–NF23Page 57
Pharmacopeial Forum:Volume No.29(4)Page 992
Phone Number:1-301-816-8339