Coccidioidin
» 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.
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.
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.
, 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 1-301-816-8385 |
(BBPP05) Biologics and Biotechnology - Proteins and Polysaccharides |
USP32–NF27 Page 2012