Capreomycin for Injection
»Capreomycin for Injection contains an amount of Capreomycin Sulfate equivalent to not less than 90.0percent and not more than 115.0percent of the labeled amount of capreomycin.
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Bacterial endotoxins á85ñ— It contains not more than 0.35USP Endotoxin Unit per mg of capreomycin.
pHá791ñ: between 4.5and 7.5,in a solution containing 30mg per mL.
Other requirements— It responds to the Identificationtest and meets the requirements for Loss on drying,Residue on ignition,Heavy metals,and Capreomycin Icontentunder Capreomycin Sulfate.It meets also the requirements under Injections á1ñ.
Assay— Proceed with Capreomycin for Injection as directed under Antibiotics—Microbial Assays á81ñ.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 335
Phone Number:1-301-816-8335