[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR640.82]

[Page 103]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS--Table of Contents
 
                       Subpart H--Albumin (Human)
 
Sec. 640.82  Tests on final product.

    Tests shall be performed on the final product to determine that it 
meets the following standards:
    (a) Protein concentration. Final product shall conform to one of the 
following concentrations: 4.0plus-minus0.25 percent; 
5.0plus-minus0.30 percent; 20.0plus-minus1.2 
percent; and 25.0plus-minus1.5 percent solution of protein.
    (b) Protein composition. At least 96 percent of the total protein in 
the final product shall be albumin, as determined by a method that has 
been approved for each manufacturer by the Director, Center for 
Biologics Evaluation and Research, Food and Drug Administration.
    (c) pH. The pH shall be 6.9plus-minus0.5 when measured in 
a solution of the final product diluted to a concentration of 1 percent 
protein with 0.15 molar sodium chloride.
    (d) Sodium concentration. The sodium concentration of the final 
product shall be 130 to 160 milliequivalents per liter.
    (e) Potassium concentration. The potassium concentration of the 
final product shall not exceed 2 milliequivalents per liter.
    (f) Heat stability. A final container sample of Albumin (Human) 
shall remain unchanged, as determined by visual inspection, after 
heating at 57  deg.C for 50 hours, when compared to its control 
consisting of a sample, from the same lot, which has not undergone this 
heating.

[42 FR 27582, May 31, 1977, as amended at 49 FR 23834, June 8, 1984; 50 
FR 4140, Jan. 29, 1985; 55 FR 11013, Mar. 26, 1990; 64 FR 26286, May 14, 
1999]