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