Sargramostim for Injection
»Sargramostim for Injection is a sterile,lyophilized preparation of Sargramostim.Its biological activity is not less than 73.0percent and not more than 146.0percent of that stated on the label in USP Sargramostim Units.It contains not less than 90.0percent and not more than 110.0percent of the total protein content stated on the label.
Packaging and storage— Preserve in hermetic containers at a temperature between 2and 8.
Labeling— Label it to state the biological activity in USP Sargramostim Units per vial and the amount of protein per vial.
Constituted solution— At the time of use,it meets the requirements for Constituted solutionsunder Injections á1ñ.
Identification— It responds to the tests for Identificationand Peptide mappingunder Sargramostim.
Bacterial endotoxins á85ñ— It contains not more than 50USP Endotoxin Units per mg.
Safety— It meets the requirements for biologics as set forth for Safety Tests—Generalunder Biological Reactivity Tests,In Vivo á88ñ.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
Uniformity of dosage units á905ñ: meets the requirements for Content Uniformity.
pHá791ñ: between 7.1and 7.7,in the solution constituted as directed in the labeling.
Water,Method Iá921ñ: not more than 2.0%.
Chromatographic purity— When constituted with water,it meets the requirements for Chromatographic purityunder Sargramostim.
Assay— When constituted with water,Sargramostim for Injection meets the requirements of the Assayunder Sargramostim.
Auxiliary Information— Staff Liaison:Larry N.Callahan,Ph.D.,Scientist
Expert Committee:(BNT)Biotechnology and Natural Therapeutics/Diagnostics
USP28–NF23Page 1755
Phone Number:1-301-816-8385