Tests shall be performed on the final product to determine that it meets the following standards:
(a)Protein concentration. The final product shall be a 5.0 ±0.30 percent solution of protein.
(b)Protein composition. The total protein in the final product shall consist of at least 83 percent albumin, and no more than 17 percent globulins. No more than 1 percent of the total protein shall be gamma globulin. The protein composition shall be 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 7.0 ±0.3 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 Plasma Protein Fraction (Human) shall remain unchanged, as determined by visual inspection, after heating at 57 °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 27583, May 31, 1977, as amended at 49 FR 23834, June 8, 1984; 55 FR 11013, Mar. 26, 1990; 64 FR 26286, May 14, 1999; 65 FR 13679, Mar. 14, 2000]
Title 21 published on 2014-04-01.
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