Erythromycin Lactobionate for Injection

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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C₃₇H₆₇NO₁₃ .C₁₂H₂₂O₁₂         1092.22

Erythromycin mono(4-O-B-D-galactopyranosyl-D-gluconate) (salt).

Erythromycin lactobionate (1:1) (salt) CAS RN: 3847-29-8.

Erythromycin Lactobionate for Injection is a sterile, dry mixture of erythromycin lactobionate and a suitable preservative. It contains the equivalent of not less than 90.0 percent and not more than 120.0 percent of the labeled amount of erythromycin (C₃₇H₆₇NO₁₃)

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 Lactobionate RS

Constituted solution-At the time of use, it meets the requirements for Injections and Implanted Drug Products (1), Specific Tests, Completeness and clarity of solutions.

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Identification, SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197M _{(CN 1-May-2020)}: the specimen and the Reference

Standard being previously dried in vacuum at a pressure not exceeding 5 mm of mercury at 60° for 3 hours.

BACTERIAL ENDOTOXINS TEST (85). It contains not more than 1.0 USP Endotoxin Unit per mg of erythromycin.

PH (791): between 6.5 and 7.5, in a solution containing the equivalent of 50 mg of erythromycin per mL.

WATER DETERMINATION, Method / (921): not more than 5.0%,

PARTICULATE MATTER IN INJECTIONS (788): meets the requirements for small-volume injections when the constituted solution is diluted with filtered water to a concentration of not more than 5 mg of erythromycin base per mL before the test is performed.

Other requirements-It meets the requirements under Injections and Implanted Drug Products (1).

Assay-Proceed as directed for erythromycin under Antibiotics-Microbial Assays (81), using Erythromycin Lactobionate for Injection constituted as directed in the labeling. Withdraw all of the withdrawable contents where the package is represented as being a single-dose container, or, where the labeling specifies the amount of erythromycin equivalent in a given volume of the resultant preparation, withdraw an accurately measured volume. Dilute quantitatively with water to obtain a stock solution containing the equivalent of about 10 mg of erythromycin per mL. Dilute this stock solution quantitatively with Buffer B.3 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.