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CVB-DAT-0140.04 Page 1 of 2

Controlled by: APHIS Center for Veterinary Biologics

United States Department of Agriculture

Animal and Plant Health Inspection Service

Center for Veterinary Biologics

P. O. Box 844

Ames, IA 50010

1. Reagent Name: Clostridium perfringens Type C (beta) Antitoxin

2. Strain or Source: Not Applicable

3. Lot Number: IRP 637

4. Fill Date: December 7, 2016

5. Expiration Date: February 28, 2029

6. Intended Use: IRP 637 serves as the standard antitoxin when conducting C. perfringens 

type C (beta) toxin-neutralization tests in mice.

7. Instructions for Use: C. perfringens type C (beta) antitoxin IRP 637 contains 550 units 

of beta antitoxin per mL. A dilution of standard antitoxin containing 10 antitoxin units per mL 

(AU/mL) is used in the toxin-neutralization test as described in 9 CFR 113.111 and 9 CFR 

113.454. The dilution is prepared by adding 0.5 mL of well mixed IRP 637 to 4.5 mL of peptone 

diluent (1.0% peptone, 0.25% sodium chloride, pH 7.2). The antitoxin is further diluted by 

adding 1.0 mL of the 1:10 dilution to 4.5 mL of diluent. The 1:10 dilution of antitoxin is stable 

when stored at -50° to -80°C and should be aliquoted for future testing.

8. Test of Reagent: Determination of antitoxin titer - The antitoxin titer was determined by 

injecting mice with 0.2 mL volume of diluted antitoxin mixed with 10 L+ toxin doses (the 

smallest amount of toxin which, when mixed with 10 units of antitoxin, causes death in at least 

80% of the animals within 24 hours) and 10 Lo toxin doses (the largest amount of toxin which, 

when mixed with 10 units of antitoxin, causes no death in animals within 24 hours). The 

antitoxin titer of IRP 637 was confirmed by comparing the results of mice injected with toxinantitoxin mixtures containing 1.0 mL of IRP 637 possessing 10 beta antitoxin units per mL with 

the results of mice injected with toxin-antitoxin mixtures containing 1.0 mL of the WHO 

International Standard for C. perfringens beta Antitoxin possessing 10 beta antitoxin units per 

mL.

Sterility test - IRP 637 was tested for sterility according to 9 CFR 113.26. 

Precautions: There are no known hazards associated with the use of this reagent.
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CVB-DAT-0140.04 Page 2 of 2

Controlled by: APHIS Center for Veterinary Biologics

9. Container Size, Type, Weight, or Volume: Freestanding micro tubes (1.5 mL) 

containing 0.6 mL of antitoxin. 

10. Storage Conditions: Store at -50° to -80°C.

11. CVB Technical Contact: Center for Veterinary Biologics, Bacteriology Section, 

(515) 337-6100 or FAX (515) 337-7673.

12. Origin and Passage History: Not applicable

13. Method of Preparation: Goats received multiple injections of a C. perfringens type C 

beta commercially prepared toxoid, CVB prepared toxoid and toxin during a 3 month period. 

The antitoxin was passed through a sterile Sartorius filtration unit containing a 0.1-μm 

membrane. No preservatives were added to the antitoxin.

14. Other: None

Reagent orders and feedback should be sent including phone number to the following email 

address: VS.DB.CVB.Reagent.Requests@usda.gov

Reagent orders forms (APHIS Form 2018) can be found on the CVB website.