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Erythromycin Ethylsuccinate Injection
»Erythromycin Ethylsuccinate Injection is a sterile solution of Erythromycin Ethylsuccinate in Polyethylene Glycol 400,and contains 2percent of butyl aminobenzoate and a suitable preservative.It contains the equivalent of not less than 90.0percent and not more than 115.0percent of the labeled amount of erythromycin (C37H67NO13).
Packaging and storage—
Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass.
Sterility á71ñ—
It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined,using a membrane filter resistant to the solvent effect of polyethylene glycol 400.
Water,Method Iá921ñ:
not more than 1.5%,20mLof methanol containing 10%of imidazole being used in place of methanol in the titration vessel.
Other requirements—
It meets the requirements under Injections á1ñ.
Assay—
Proceed as directed for erythromycin under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of Injection diluted quantitatively with methanol to yield a solution containing the equivalent of about 1mg of erythromycin per mL.Dilute a portion of this stock solution quantitatively with Buffer No.3to obtain a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information—
Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 766
Phone Number:1-301-816-8335
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