[Code of Federal Regulations] [Title 21, Volume 7] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR640.103] [Page 106-107] TITLE 21--FOOD AND DRUGS DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued) PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS--Table of Contents Subpart J--Immune Globulin (Human) Sec. 640.103 The final product. (a) Final solution. The final product shall be a 16.5plus-minus1.5 percent solution of [[Page 107]] 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]