U.S. PHARMACOPEIA

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Sargramostim for Injection
» Sargramostim for Injection is a sterile, lyophilized preparation of Sargramostim. Its biological activity is not less than 73.0 percent and not more than 146.0 percent of that stated on the label in USP Sargramostim Units. It contains not less than 90.0 percent and not more than 110.0 percent of the total protein content stated on the label.
Packaging and storage— Preserve in hermetic containers at a temperature between 2 and 8.
Labeling— Label it to state the biological activity in USP Sargramostim Units per vial and the amount of protein per vial.
USP Reference standards 11— USP Sargramostim RS. USP Endotoxin RS.
Constituted solution— At the time of use, it meets the requirements for Constituted solutions under Injections 1.
Identification— It responds to the tests for Identification and Peptide mapping under Sargramostim.
Bacterial endotoxins 85— It contains not more than 50 USP Endotoxin Units per mg.
Safety— It meets the requirements for biologics as set forth for Safety Tests—General under Biological Reactivity Tests, In Vivo 88.
Sterility 71— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
Uniformity of dosage units 905: meets the requirements for Content Uniformity.
pH 791: between 7.1 and 7.7, in the solution constituted as directed in the labeling.
Water, Method I 921: not more than 2.0%.
Chromatographic purity— When constituted with water, it meets the requirements for Chromatographic purity under Sargramostim.
Assay— When constituted with water, Sargramostim for Injection meets the requirements of the Assay under Sargramostim.
Auxiliary Information— Staff Liaison : Larry N. Callahan, Ph.D., Scientist
Expert Committee : (BBPP05) Biologics and Biotechnology - Proteins and Polysaccharides
USP29–NF24 Page 1949
Phone Number : 1-301-816-8385