§640.103. The final product.
21 C.F.R. § 640.103
Final solution. The final product shall be a 16.5 ±1.5 percent solution of globulin containing 0.3 molar glycine and a preservative.
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, and revision history
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]