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Erythromycin Estolate for Oral Suspension
» Erythromycin Estolate for Oral Suspension is a dry mixture of Erythromycin Estolate 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 115.0 percent of the labeled amount of erythromycin (C37H67NO13).
Packaging and storage— Preserve in tight containers.
Identification— Prepare a test solution by mixing a quantity of Erythromycin Estolate for Oral Suspension with methanol to obtain a concentration equivalent to about 20 mg of erythromycin per mL. Prepare a Standard solution of USP Erythromycin Estolate RS in methanol containing the equivalent of 20 mg of erythromycin per mL. Apply separately 3 µL of each solution to a thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel. Proceed as directed in the Identification test under Erythromycin Delayed-Release Capsules, beginning with “Place the plate in an unlined chromatographic chamber.”
Uniformity of dosage units 905
Deliverable volume 698: meets the requirements.
pH 791: between 5.0 and 7.0 (if pediatric drops, between 5.0 and 5.5), in the suspension constituted as directed in the labeling.
Water, Method I 921: not more than 2.0%, 20 mL of methanol containing 10% of imidazole being used in place of methanol in the titration vessel.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Constitute Erythromycin Estolate for Oral Suspension as directed in the labeling, and proceed as directed in the Assay under Erythromycin Estolate Oral Suspension.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 835
Phone Number : 1-301-816-8223