Erythromycin Ethylsuccinate for Oral Suspension

» Erythromycin Ethylsuccinate for Oral Suspension is a dry mixture of Erythromycin Ethylsuccinate with one or more suitable buffers, colors, diluents, dispersants, and flavors. 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 in tight containers.

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USP Erythromycin RS

USP Erythromycin Ethylsuccinate RS

Identification— To a quantity of Erythromycin Ethylsuccinate for Oral Suspension add a volume of methanol sufficient to yield a solution containing the equivalent of about 2.5 mg of erythromycin per mL, and stir for 30 minutes. Centrifuge a portion of this mixture, and use the clear supernatant as the test solution. Proceed as directed in the Identification test under Erythromycin Ethylsuccinate Oral Suspension, beginning with “Prepare a Standard solution.”

Uniformity of dosage units

905

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for solid packaged in single-unit containers : meets the requirements.

Deliverable volume

698

: meets the requirements.

791

: between 7.0 and 9.0, in the suspension constituted as directed in the labeling.

Loss on drying

731

— Dry about 100 mg in a capillary-stoppered bottle in vacuum at 60

for 3 hours: it loses not more than 1.0% of its weight.

Assay— Constitute Erythromycin Ethylsuccinate for Oral Suspension as directed in the labeling, and proceed as directed in the Assay under Erythromycin Ethylsuccinate Oral Suspension.

Auxiliary Information— Please check for your question in the FAQs before contacting USP.

Topic/Question	Contact	Expert Committee
Monograph	Ahalya Wise, M.S. Senior Scientific Liaison 1-301-816-8161	(SM12010) Monographs - Small Molecules 1
Reference Standards	RS Technical Services 1-301-816-8129 rstech@usp.org

USP35–NF30 Page 3089