Packaging and storage— Preserve in tight containers.

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

USP Reference standards á11ñ— 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 20mg of erythromycin per mL.Prepare a Standard solution of USP Erythromycin Estolate RSin methanol containing the equivalent of 20mg of erythromycin per mL.Apply separately 3µLof each solution to a thin-layer chromatographic plate (see Chromatography á621ñ)coated with a 0.25-mm layer of chromatographic silica gel.Proceed as directed in the Identificationtest 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 20mg of erythromycin,to a separator,and proceed as directed in the Identification test under Erythromycin Estolate Oral Suspension,beginning with “Add 15mLof 0.02Nsodium hydroxide.”]

Disintegration á701ñ: 30minutes,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 á905ñ: meet the requirements.

Water,Method Iá921ñ: not more than 5.0%;or if chewable tablets,not more than 4.0%,20mLof methanol containing 10%of imidazole being used in place of methanol in the titration vessel.

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

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 764

Phone Number:1-301-816-8335