{"data":{"id":"us/21-cfr-640.103","jurisdiction":"us","citation":"21 CFR 640.103","heading":"The final product.","body":"(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.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER F—BIOLOGICS","PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS","Subpart J—Immune Globulin (Human)"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"da808b3128dcb060c6ae6866b3606e4e8b99899ae5176e693241100d34f15ab5","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-640.102","next":"us/21-cfr-640.104"},"notice":"GroundRules: Original legal text. Not legal advice."}