Packaging and storage— Preserve in tight containers.

Labeling— Label the Tablets to indicate whether they are to be chewed before swallowing.

USP Reference standards 11— USP Erythromycin RS. USP Erythromycin Estolate RS.

Identification— Prepare a test solution by mixing a quantity of finely powdered Tablets 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.” [NOTE—Use the following procedure for chewable Tablets. Transfer a quantity of finely powdered Tablets, equivalent to about 20 mg of erythromycin, to a separator, and proceed as directed in the Identification test under Erythromycin Estolate Oral Suspension, beginning with “Add 15 mL of 0.02 N sodium hydroxide.”]

Disintegration 701: 30 minutes, proceeding as directed for Uncoated Tablets, except to use disks and to use simulated gastric fluid as the immersion fluid instead of water. [NOTE—Chewable tablets are exempt from this requirement.]

Uniformity of dosage units 905: meet the requirements.

Water, Method I 921: not more than 5.0%; or if chewable tablets, not more than 4.0%, 20 mL of methanol containing 10% of imidazole being used in place of methanol in the titration vessel.

Residual solvents 467: meet the requirements.

Assay— Proceed with Tablets as directed in the Assay under Erythromycin Estolate Capsules.

Expert Committee : (MDANT05) Monograph Development-Antibiotics

USP29–NF24 Page 836

Phone Number : 1-301-816-8223