21 C.F.R. Subpart C—Standard Preparations and Limits of Potency
Title 21 - Food and Drugs
Standard preparations made available by the Center for Biologics Evaluation and Research shall be applied in testing, as follows: (a) Potency standards. Potency standards shall be applied in testing for potency all forms of the following:
Antibodies Botulism Antitoxin, Type A. Botulism Antitoxin, Type B. Botulism Antitoxin, Type E. Diphtheria Antitoxin. Histolyticus Antitoxin. Oedematiens Antitoxin. Perfringens Antitoxin. Antipertussis Serum. Antirabies Serum. Sordellii Antitoxin. Staphylococcus Antitoxin. Tetanus Antitoxin. Vibrion Septique Antitoxin. Antigens Cholera Vaccine, Inaba serotype. Cholera Vaccine, Ogawa serotype. Diphtheria Toxin for Schick Test. Pertussis Vaccine. Tuberculin, Old. Tuberculin, Purified Protein Derivative. Typhoid Vaccine. Blood Derivative Thrombin. (b) Opacity standard. The U.S. Opacity Standard shall be applied in estimating the bacterial concentration of all bacterial vaccines. The assigned value of the standard when observed visually is 10 units. The assigned value of the standard when observed with a photometer is (1) 10 units when the wavelength of the filter is 530 millimicrons, (2) 10.6 units when the wavelength of the filter is 650 millimicrons, and (3) 9 units when the wavelength of the filter is 420 millimicrons. [38 FR 32056, Nov. 20, 1973, as amended at 41 FR 10429, Mar. 11, 1976; 41 FR 18295, May 3, 1976; 49 FR 23834, June 8, 1984; 55 FR 11013, Mar. 26, 1990]
Link to an amendment published at 70 FR 75028, Dec. 19, 2005. The potency of the following products shall be not less than that set forth below and products dispensed in the dried state shall represent liquid products having the stated limitations.
Antibodies Diphtheria Antitoxin, 500 units per milliliter. Tetanus Antitoxin, 400 units per milliliter. Tetanus Immune Globulin (Human), 50 units of tetanus antitoxin per milliliter. Antigens Cholera Vaccine, 8 units each of Inaba and Ogawa serotype antigens per milliliter. Pertussis Vaccine, 12 units per total human immunizing dose. Typhoid Vaccine, 8 units per milliliter. [41 FR 10429, Mar. 11, 1976, as amended at 41 FR 18295, May 3, 1976]
Title 21: Food and Drugs
PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS
Subpart C—Standard Preparations and Limits of Potency
§ 610.20 Standard preparations.
§ 610.21 Limits of potency.
