Sisomicin Sulfate Injection
»Sisomicin Sulfate Injection is a sterile solution of Sisomicin Sulfate in Water for Injection.It contains the equivalent of not less than 90.0percent and not more than 120.0percent of the labeled amount of sisomicin (C19H37N5O7).It may contain one or more suitable buffers,chelating agents,and preservatives.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass.
Identification— It responds to Identificationtest Aunder Sisomicin Sulfate.
Bacterial endotoxins á85ñ— It contains not more than 0.5USP Endotoxin Unit per mg of sisomicin.
pHá791ñ: between 2.5and 5.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Proceed as directed under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of Sisomicin Sulfate Injection diluted quantitatively and stepwise with Buffer No.3to yield a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard (0.1µg of sisomicin per mL).
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1773
Phone Number:1-301-816-8335