21 CFR § 640.92 - Tests on final product.

---
identifier: "/us/cfr/t21/s640.92"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 640.92 - Tests on final product."
title_number: 21
title_name: "Food and Drugs"
section_number: "640.92"
section_name: "Tests on final product."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "F"
subchapter_name: "BIOLOGICS"
part_number: "640"
part_name: "ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264."
regulatory_source: "38 FR 32089, Nov. 20, 1973, unless otherwise noted."
cfr_part: "640"
---


# 640.92 Tests on final product.

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]