U.S. PHARMACOPEIA

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Erythromycin Ethylsuccinate Injection
» Erythromycin Ethylsuccinate Injection is a sterile solution of Erythromycin Ethylsuccinate in Polyethylene Glycol 400, and contains 2 percent of butyl aminobenzoate and a suitable preservative. It contains the equivalent of not less than 90.0 percent and not more than 115.0 percent of the labeled amount of erythromycin (C37H67NO13).
Packaging and storage— Preserve in single-dose or in multiple-dose containers, preferably of Type I glass.
Sterility 71— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined, using a membrane filter resistant to the solvent effect of polyethylene glycol 400.
Water, Method I 921: not more than 1.5%, 20 mL of methanol containing 10% of imidazole being used in place of methanol in the titration vessel.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay— Proceed as directed for erythromycin under Antibiotics—Microbial Assays 81, using an accurately measured volume of Injection diluted quantitatively with methanol to yield a solution containing the equivalent of about 1 mg of erythromycin per mL. Dilute a portion of this stock solution quantitatively with Buffer No. 3 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
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