Sterile Erythromycin Ethylsuccinate

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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Sterile Erythromycin Ethylsuccinate is Erythromycin Ethylsuccinate suitable for parenteral use. It has a potency equivalent to not less than 765 μg of erythromycin (C₃₆H₆₇NO₁₃) per mg, calculated on the anhydrous basis.

1 Packaging and storage

Preserve as described in Packaging and Storage Requirements 〈659〉, Injection Packaging, Packaging for constitution.

USP Reference standards 〈11〉—

USP Erythromycin RS

USP Erythromycin Ethylsuccinate RS

Change to read:

Identification, Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197S (CN 1-May-2020) —

Solution: 1 in 100.

Medium: chloroform.

Cell size: 1.0 mm.

Sterility Tests 〈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.

2 Other requirements

It conforms to the Definition and meets the requirements for Water, Residue on ignition, Crystallinity, and the Assay under Erythromycin Ethylsuccinate.