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.
USP Reference standards 11
USP Erythromycin RS Click to View Structure
USP Erythromycin Ethylsuccinate RS Click to View Structure
Identification, Infrared Absorption 197S
Solution: 1 in 100.
Medium: chloroform.
Cell size: 1.0 mm.
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%.
Other requirements— It conforms to the Definition and meets the requirements for Water, Residue on ignition, Crystallinity, and the Assay under Erythromycin Ethylsuccinate.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Senior Scientific Liaison
(SM12010) Monographs - Small Molecules 1
Reference Standards RS Technical Services
71 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
(GCM2010) General Chapters - Microbiology
USP35–NF30 Page 3088
Pharmacopeial Forum: Volume No. 34(5) Page 1158