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.
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— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Scientist
1-301-816-8161
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 1971