Packaging and storage—
Preserve in tight containers.
Labeling—
Label the Tablets to indicate whether they are to be chewed before swallowing.
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 0.02
Nsodium 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.
]
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.