Clostridium Perfringens Type C Antitoxin.

CFR · 2024-01-01 · US · Title 9

Clostridium Perfringens Type C Antitoxin is a specific antibody product containing antibodies directed against the toxin of (a) Each serial shall meet the applicable general requirements provided in § 113.450. (b) (1) When used in this test, the following words and terms shall mean: (i) (ii) (iii) (iv) (v) (vi) (2) The antitoxin content of the test sample shall be determined as follows: (i) Make a dilution of Standard Antitoxin to contain 10 International Units of antitoxin per ml. (ii) Make one dilution of Standard Toxin to contain 10 L (iii) Dilute 1 ml of the test sample with 49 ml of diluent and combine 1 ml of this dilution with 1 ml of the Standard Toxin diluted to contain 10 L (iv) Combine 10 International Units of Standard Antitoxin with 10 L (v) Neutralize all toxin-antitoxin mixtures at room temperature for 1 (vi) Five Swiss white mice, each weighing 16-20 grams, shall be used for each toxin-antitoxin mixture. A dose of 0.2 ml shall be injected intravenously into each mouse. Conclude the test 24 hours post-injection and record all deaths. (3) (ii) If less than 80 percent of the mice inoculated with the mixture of 10 International Units of Standard Antitoxin and 10 L (iii) If any mice inoculated with the mixture of Clostridium Perfringens Type C Antitoxin diluted 1:50 and 10 L

official document · source cfr-2024 · id 9:§ 113.454