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Erythromycin Delayed-Release Tablets
» Erythromycin Delayed-Release Tablets contain not less than 90.0 percent and not more than 120.0 percent of the labeled amount of erythromycin (C37H67NO13).
Packaging and storage— Preserve in tight containers.
Labeling— The label indicates that the Tablets are enteric-coated. The labeling indicates the Drug Release Test with which the product complies.
Labeling— The label indicates that the Tablets are enteric-coated. The labeling indicates the Dissolution Test with which the product complies.
(Official April 1, 2006)
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.”
Drug release, Method B 724—
Test 1— If the product complies with this test, the labeling indicates that it meets USP Drug Release Test 1.
Apparatus 1: 100 rpm.
Times: 60 minutes, Stage 1; 60 minutes, Stage 2.
Acid stage— Using 900 mL of simulated gastric fluid TS (prepared without pepsin) in place of 0.1 N hydrochloric acid, conduct this stage of the test for 1 hour, and do not perform an analysis of the medium.
Buffer stage— Using 900 mL of 0.05 M pH 6.8 phosphate buffer (see Buffer Solutions in the section Reagents, Indicators, and Solutions), conduct this stage of the test for 60 minutes.
Test solution— If necessary, dilute a filtered portion of the solution under test with Dissolution Medium to obtain a solution having a concentration of about 0.28 mg of erythromycin per mL, and mix.
Procedure— Transfer a 2.0-mL portion of the Test solution to a suitable separator. Add 6 mL of pH 1.2 buffer (see Solutions in the section Reagents, Indicators, and Solutions), and 8 mL of a solution of bromocresol purple, prepared by dissolving 1 g of bromocresol purple in 1 L of pH 4.5 phosphate buffer, and mix. Extract with 40.0 mL of chloroform. Determine the amount of C37H67NO13 dissolved from UV absorbances at the wavelength of maximum absorbance at about 410 nm using the chloroform extracts. Similarly prepare a Standard solution, having a known concentration of USP Erythromycin RS, and treat similarly.
Test 2— If the product complies with this test, the labeling indicates that it meets USP Drug Release Test 2. Proceed as directed under Test 1, except to use Apparatus 2 at 75 rpm.
Dissolution 711— Proceed as directed for Procedure for Method B under Apparatus 1 and Apparatus 2, Delayed-Release Dosage Forms.
Test 1— If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 1.
Apparatus 1: 100 rpm.
Times: 60 minutes, Stage 1; 60 minutes, Stage 2.
Acid stage— Using 900 mL of simulated gastric fluid TS (prepared without pepsin) in place of 0.1 N hydrochloric acid, conduct this stage of the test for 1 hour, and do not perform an analysis of the medium.
Buffer stage— Using 900 mL of 0.05 M pH 6.8 phosphate buffer (see Buffer Solutions in the section Reagents, Indicators, and Solutions), conduct this stage of the test for 60 minutes.
Test solution— If necessary, dilute a filtered portion of the solution under test with Dissolution Medium to obtain a solution having a concentration of about 0.28 mg of erythromycin per mL, and mix.
Procedure— Transfer a 2.0-mL portion of the Test solution to a suitable separator. Add 6 mL of pH 1.2 buffer (see Solutions in the section Reagents, Indicators, and Solutions), and 8 mL of a solution of bromocresol purple, prepared by dissolving 1 g of bromocresol purple in 1 L of pH 4.5 phosphate buffer, and mix. Extract with 40.0 mL of chloroform. Determine the amount of C37H67NO13 dissolved from UV absorbances at the wavelength of maximum absorbance at about 410 nm using the chloroform extracts. Similarly prepare a Standard solution, having a known concentration of USP Erythromycin RS, and treat similarly.
Test 2— If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2. Proceed as directed under Test 1, except to use Apparatus 2 at 75 rpm.
(Official April 1, 2006)
Uniformity of dosage units 905: meet the requirements.
Water, Method I 921: not more than 6.0%, 20 mL of methanol containing 10% of imidazole being used in place of methanol in the titration vessel.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Assay— Place not fewer 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 No. 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 No. 3 to yield a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 833
Pharmacopeial Forum : Volume No. 31(1) Page 154
Phone Number : 1-301-816-8223