U.S. PHARMACOPEIA

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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 90.0 percent and not more than 120.0 percent 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 I glass.
Identification— It responds to Identification test A under Sisomicin Sulfate.
Bacterial endotoxins 85— It contains not more than 0.5 USP Endotoxin Unit per mg of sisomicin.
pH 791: between 2.5 and 5.5.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay— Proceed as directed under Antibiotics—Microbial Assays 81, using an accurately measured volume of Sisomicin Sulfate Injection diluted quantitatively and stepwise with Buffer No. 3 to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard (0.1 µg of sisomicin per mL).
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1967
Phone Number : 1-301-816-8223