Hepatitis B Virus Vaccine Inactivated
»Hepatitis B Virus Vaccine Inactivated is a sterile preparation consisting of a suspension of particles of Hepatitis Bsurface antigen (HBsAg)isolated from the plasma of HBsAg carriers;treated with pepsin at pH2,8Murea,and 1:4,000formalin so as to inactivate any hepatitis Bvirus and any representative viruses from all known virus groups that may be present;purified by ultracentrifugation and biochemical procedures and standardized to a concentration of 35µg to 55µg of Lowry (HBsAg)protein per mL.The preparation is adsorbed on aluminum hydroxide and diluted to a concentration of 20µg Lowry protein per mLor other appropriate concentration,depending on the intended use.The Vaccine meets the requirements for potency in animal tests using mice and by a quantitative parallel line radioimmunoassay.It contains not more than 0.62mg of aluminum per mLand not more than 0.02percent of residual free formaldehyde.It contains thimerosal as a preservative.It meets the requirements of the tests for pyrogen and for general safety (see Safety Tests—Generalunder Biological Reactivity Tests,In Vivo á88ñ).
Packaging and storage— Preserve at a temperature between 2and 8.
Expiration date— The expiration date is 3years from the date of manufacture,the date of manufacture being the date on which the last valid potency test was initiated.
Labeling— Label it to state the content of HBsAg protein per recommended dose.Label it also to state that it is to be shaken before use and that it is not to be frozen.
Auxiliary Information— Staff Liaison:Tina S.Morris,Ph.D.,Senior Scientist
Expert Committee:(VVI)Vaccines,Virology,and Immunology
USP28–NF23Page 943
Phone Number:1-301-816-8397
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