Mumps Skin Test Antigen
»Mumps Skin Test Antigen conforms to the regulations of the FDAconcerning biologics (see Biologics á1041ñ).It is a sterile suspension of formaldehyde-inactivated mumps virus prepared from the extra-embryonic fluids of the mumps virus-infected chicken embryo,concentrated and purified by differential centrifugation,and diluted with isotonic sodium chloride solution.It contains not less than 20complement-fixing units in each mL.It contains approximately 0.006Mglycine as a stabilizing agent,and it contains a preservative.
Packaging and storage— Preserve at a temperature between 2and 8.
Expiration date— The expiration date is not later than 18months after date of manufacture or date of issue from manufacturer's cold storage (5,1year).
Labeling— Label it to state that it was prepared in embryonated chicken eggs and that a separate syringe and needle are to 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 1317
Phone Number:1-301-816-8397