---
kind: "section"
citation: "21 C.F.R. § 640.82"
title: "21"
number: "640.82"
heading: "Tests on final product."
url: "https://uscodex.org/cfr/21/640.82"
---

# §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: 4.0 ±0.25 percent; 5.0 ±0.30 percent; 20.0 ±1.2 percent; and 25.0 ±1.5 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 6.9 ±0.5 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 °C for 50 hours, when compared to its control consisting of a sample, from the same lot, which has not undergone this heating.

## Notes

### Amendments

[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]

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264.

### Source

Source: 38 FR 32089, Nov. 20, 1973, unless otherwise noted.

### Amendments

[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]