» Coccidioidin conforms to the regulations of the FDA concerning biologics (see Biologics 1041). It is a sterile solution containing the antigens obtained from the by-products of mycelial growth or from the spherules of the fungus Coccidioides immitis. It has a potency such that the 1:100 dilution is bioequivalent to the U.S. Reference Coccidioidin 1:100. It contains a suitable antimicrobial agent.
Packaging and storage— Preserve at a temperature between 2 and 8.
Expiration date— The expiration date is not later than 3 years after date of issue from manufacturer's cold storage (5, 1 year) for the mycelial product and not later than 18 months after date of issue from manufacturer's cold storage (5, 18 months) for the spherule-derived product.
Labeling— Label it to state that any dilutions made of the product should be stored in a refrigerator and used within 24 hours. Label it also to state that a separate syringe and needle shall be used for each individual injection.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Larry N. Callahan, Ph.D.
Senior Scientist
(BBPP05) Biologics and Biotechnology - Proteins and Polysaccharides
USP32–NF27 Page 2012