U.S. PHARMACOPEIA

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Capreomycin for Injection
» Capreomycin for Injection contains an amount of Capreomycin Sulfate equivalent to not less than 90.0 percent and not more than 115.0 percent of the labeled amount of capreomycin.
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1.
Constituted solution— At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Bacterial endotoxins 85— It contains not more than 0.35 USP Endotoxin Unit per mg of capreomycin.
pH 791: between 4.5 and 7.5, in a solution containing 30 mg per mL.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It responds to the Identification test and meets the requirements for Loss on drying, Residue on ignition, Heavy metals, and Capreomycin I content under Capreomycin Sulfate. It meets also the requirements under Injections 1.
Assay— Proceed with Capreomycin for Injection as directed under Antibiotics—Microbial Assays 81.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 363
Phone Number : 1-301-816-8223