Erythromycin Tablets
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
Erythromycin Tablets contain not less than 90.0 percent and not more than 120.0 percent of the labeled amount of C37H67NO13.
[NOTE-Tablets that are enteric-coated meet the requirements for Erythromycin Delayed-Release Tablets.]
Packaging and storage-Preserve in tight containers.
USP REFERENCE STANDARDS (11)-
USP Erythromycin RS
Identification-Prepare a test solution by mixing a quantity of finely powdered Tablets with methanol to obtain a concentration of about 2.5 mg of erythromycin per mL. Proceed as directed in the Identification test under Erythromycin Delayed-Release Capsules, beginning with "Prepare a Standard solution of USP Erythromycin RS."
DISSOLUTION (711)-
Medium: 0.05 M pH 6.8 phosphate buffer (see Buffer solutions in the section Reagents. Indicators and Solutions): 900 mL.
Apparatus 2: 50 rpm.
Time: 60 minutes.
Test solution-If necessary, dilute a filtered portion of the solution under test with Medium to obtain a solution having a concentration of about 0.28 mg of erythromycin per mL, and mix.
Standard solution-Dissolve an accurately weighed quantity of USP Erythromycin RS in methanol (not more than 1 ml of methanol for each 14. mg of the Reference Standard), and dilute with water, quantitatively and with mixing, to obtain a stock solution containing about 0.56 mg per mL. Immediately prior to use, dilute the stock solution quantitatively with water to obtain a Standard solution having a known concentration of about 0.28 mg per mL.
Procedure-Transfer 5.0-ml portions of the Test solution and the Standard solution to separate 25-ml, volumetric flasks, and treat each as follows: Add 2.0 ml. of water, and allow to stand for 5 minutes with intermittent swirling. Add 15.0 mL of 0.25 N sodium hydroxide, dilute with Medium to volume, and mix. Heat to 60° for 5 minutes, and allow to cool. Concomitantly determine the absorbances of these solutions at the wavelength of maximum absorbance at about 236 nm, with a suitable spectrophotometer, using blank solutions similarly prepared, except that 2.0 mL of 0.5 N sulfuric acid is substituted for the 2.0 ml, of water. Calculate the amount of C37H67NO13 dissolved.
Tolerances-Not less than 70% (Q) of the labeled amount of CHNO, is dissolved in 60 minutes.
UNIFORMITY OF DOSAGE UNITS (905): meet the requirements.
LOSS ON DRYING (731)-Dry about 100 mg of powdered Tablets in a capillary-stoppered bottle in vacuum at 60 for 3 hours: it loses not more than 5.0% of its weight.
Assay-Place not less than 4 Tablets in a high-speed glass blender jar with 200 mL of methanol, and blend for 3 minutes. Add 300 mL of Buffer B.3, and blend for 3 minutes. Proceed as directed under Antibiotics-Microbial Assays (81), using an accurately measured volume of this stock test solution diluted quantitatively with Buffer B.3 to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
