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.
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
for solid packaged in single-unit containers : meets the requirements.
Deliverable volume 698: meets the requirements.
pH 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.
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 2293