Erythromycin Ethylsuccinate for Oral Suspension, chemical structure, molecular formula, Reference Standards

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 90.0percent and not more than 120.0percent of the labeled amount of erythromycin (C37H67NO13).

Packaging and storage— Preserve in tight containers.

USP Reference standards á11ñ— 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 2.5mg of erythromycin per mL,and stir for 30minutes.Centrifuge a portion of this mixture,and use the clear supernatant as the test solution.Proceed as directed in the Identificationtest under Erythromycin Ethylsuccinate Oral Suspension,beginning with “Prepare a Standard solution.”

Uniformity of dosage units á905ñ—

FOR SOLID PACKAGED IN SINGLE-UNIT CONTAINERS :meets the requirements.

Deliverable volume á698ñ: meets the requirements.

pHá791ñ: between 7.0and 9.0,in the suspension constituted as directed in the labeling.

Loss on drying á731ñ— Dry about 100mg in a capillary-stoppered bottle in vacuum at 60

for 3hours: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 Assayunder Erythromycin Ethylsuccinate Oral Suspension.

Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 767

Phone Number:1-301-816-8335