U.S. PHARMACOPEIA

Search USP29  
Sterile Erythromycin Ethylsuccinate
» Sterile Erythromycin Ethylsuccinate is Erythromycin Ethylsuccinate suitable for parenteral use. It has a potency equivalent to not less than 765 µg of erythromycin (C37H67NO13) per mg, calculated on the anhydrous basis.
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1.
Sterility 71— It meets the requirements when tested as directed for Direct Inoculation of the Culture Medium under Test for Sterility of the Product to be Examined.
Heavy metals 231— Dissolve 1 g in 25 mL of water, and proceed as directed for Method I: the limit is 0.002%.
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, Residue on ignition, Crystallinity, and Assay under Erythromycin Ethylsuccinate.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 838
Phone Number : 1-301-816-8223