Clindamycin for Injection
»Clindamycin for Injection contains an amount of Clindamycin Phosphate having a potency equivalent to not less than 758µg of clindamycin (C18H33ClN2O5S)per mg,calculated on the anhydrous basis.
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Bacterial endotoxins á85ñ— It contains not more than 0.58USP Endotoxin Unit per mg of clindamycin.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined,6g of specimen aseptically dissolved in 200mLof Fluid Abeing used.
Other requirements— It conforms to the Definition,responds to the Identificationtest,and meets the requirements for pH,Water,Crystallinity,and Assayunder Clindamycin Phosphate.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 497
Phone Number:1-301-816-8335