21 CFR 640.103 - The final product.

§ 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]

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