Botulism Antitoxin
» Botulism Antitoxin conforms to the regulations of the federal Food and Drug Administration concerning biologics (see Biologics 1041). It is a sterile, nonpyrogenic solution of the refined and concentrated antitoxic antibodies, chiefly globulins, obtained from the blood of healthy horses that have been immunized against the toxins produced by the type A and type B and/or type E strains of Clostridium botulinum. Its potency is determined with the U.S. Standard Botulism Antitoxin of the relevant type, tested by neutralizing activity in mice of the corresponding U.S. Control Botulism Test Toxin. It contains not more than 20.0 percent of solids, and contains a suitable antimicrobial agent.
Packaging and storage— Preserve in single-dose containers only, at a temperature between 2 and 8.
Expiration date— The expiration date for Antitoxin containing a 20% excess of potency is not later than 5 years after date of issue from manufacturer's cold storage (5, 1 year; or 0, 2 years).
Labeling— Label it to state that it was prepared from horse blood.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Tina S. Morris, Ph.D.
Director,Biologics and Biotechnology
(BBVV05) Biologics and Biotechnology - Vaccines and Virology
USP32–NF27 Page 1701