»Histoplasmin conforms to the regulations of the FDAconcerning biologics (see Biologics á1041ñ).It is a clear,colorless,sterile solution containing standardized culture filtrates of Histoplasma capsulatumgrown on liquid synthetic medium.It has a potency of the 1:100dilution equivalent to and determined in terms of the Histoplasmin Reference diluted 1:100tested in guinea pigs.It may contain a suitable antimicrobial agent.
Packaging and storage— Preserve at a temperature between 2and 8.
Expiration date— The expiration date is not later than 2years after date of issue from manufacturer's cold storage (5,1year).
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— Staff Liaison:Tina S.Morris,Ph.D.,Senior Scientist
Expert Committee:(VVI)Vaccines,Virology,and Immunology
USP28–NF23Page 947
Phone Number:1-301-816-8397