U.S. PHARMACOPEIA

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Mumps Skin Test Antigen
» Mumps Skin Test Antigen conforms to the regulations of the FDA concerning biologics (see Biologics 1041). 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 20 complement-fixing units in each mL. It contains approximately 0.006 M glycine as a stabilizing agent, and it contains a preservative.
Packaging and storage— Preserve at a temperature between 2 and 8.
Expiration date— The expiration date is not later than 18 months after date of manufacture or date of issue from manufacturer's cold storage (5, 1 year).
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.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Auxiliary Information— Staff Liaison : Tina S. Morris, Ph.D., Senior Scientist
Expert Committee : (BBVV05) Biologics and Biotechnology - Vaccines and Virology
USP29–NF24 Page 1463
Phone Number : 1-301-816-8397