» Histoplasmin conforms to the regulations of the FDA concerning biologics (see Biologics 1041). It is a clear, colorless, sterile solution containing standardized culture filtrates of Histoplasma capsulatum grown on liquid synthetic medium. It has a potency of the 1:100 dilution equivalent to and determined in terms of the Histoplasmin Reference diluted 1:100 tested in guinea pigs. It may contain a suitable antimicrobial agent.
Packaging and storage— Preserve at a temperature between 2 and 8.
Expiration date— The expiration date is not later than 2 years after date of issue from manufacturer's cold storage (5, 1 year).
Labeling— Label it to state that only the diluent supplied is to be used for making dilutions, and that it is not to be injected other than intradermally. 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 Tina S. Morris, Ph.D.
Director,Biologics and Biotechnology
(BBVV05) Biologics and Biotechnology - Vaccines and Virology
USP32–NF27 Page 2559