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Code of Federal Regulations Title 21. Food and Drugs § 21.640.103 The final product

Current as of January 02, 2025 | Updated by Findlaw Staff

(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.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.640.103 The final product - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-640-103/

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