U.S. PHARMACOPEIA

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Clindamycin for Injection
» Clindamycin for Injection contains an amount of Clindamycin Phosphate having a potency equivalent to not less than 758 µg of clindamycin (C18H33ClN2O5S) per mg, calculated on the anhydrous basis.
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1.
Bacterial endotoxins 85 It contains not more than 0.58 USP Endotoxin Unit per mg of clindamycin.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined, 6 g of specimen aseptically dissolved in 200 mL of Fluid A being used.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It conforms to the Definition, responds to the Identification test, and meets the requirements for pH, Water, Crystallinity, and Assay under Clindamycin Phosphate.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 541
Phone Number : 1-301-816-8223