Erythromycin Injection
If you find any inaccurate information, please let us know by providing your feedback here
This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
Erythromycin Injection is a sterile solution of Erythromycin in a polyethylene glycol vehicle. It contains not less than 90.0 percent and not more than 120.0 percent of the labeled amount of C37H67NO13.
Packaging and storage-Preserve in multiple-dose containers.
Labeling-Label it to indicate that it is for veterinary use only. Label it to state that it is for intramuscular administration only.
USP REFERENCE STANDARDS (11)-
USP Erythromycin RS
Identification-Transfer a quantity of Injection, equivalent to about 5 mg of erythromycin, to a separator containing 50 mL of solvent hexane. Shake until dissolved. Extract with three separate 20-mL portions of methanol. Combine the methanol extracts in a beaker, and evaporate to dryness. Dissolve the residue in 2 mL of methanol (test solution). Proceed as directed in the Identification test under Erythromycin Delayed-Release Capsules, beginning with "Prepare a Standard solution of USP Erythromycin RS."
WATER DETERMINATION, Method (921): not more than 1.0%, 20 mL of a mixture of toluene and methanol (7:3) being used in place of methanol in the titration vessel.
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.
Other requirements-It meets the requirements under Injections and Implanted Drug Products (1).
Assay-Transfer an accurately measured volume of Injection, equivalent to about 50 mg of erythromycin, to a separator containing 50 mL of solvent hexane. Shake until dissolved. Wash with four separate 20-mL portions of a mixture of methanol and water (4:1). Combine the washings in a 100-ml volumetric flask, dilute with the methanol and water solution to volume, and mix. Proceed as directed for erythromycin under Antibiotics-Microbial Assays (81), using an accurately measured volume of this stock solution diluted quantitatively with Buffer B.3 to yield a Test Dilution having a concentration of erythromycin assumed to be equal to the median dose level of the Standard.
