---
kind: "section"
citation: "21 C.F.R. § 640.103"
title: "21"
number: "640.103"
heading: "The final product."
url: "https://uscodex.org/cfr/21/640.103"
---

# §640.103. The final product.

- (a) **Final solution.** The final product shall be a 16.5 ±1.5 percent solution of globulin containing 0.3 molar glycine and a preservative.
- (b) **Protein composition.** At least 96 percent of the total protein shall be immunoglobulin G (IgG), 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.

## Notes

### Amendments

[38 FR 32089, Nov. 20, 1973, as amended at 64 FR 26287, 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

[38 FR 32089, Nov. 20, 1973, as amended at 64 FR 26287, May 14, 1999]