Erythromycin Delayed-Release Tablets
»Erythromycin Delayed-Release Tablets contain not less than 90.0percent and not more than 120.0percent of the labeled amount of C37H67NO13.
Packaging and storage— Preserve in tight containers.
Labeling— The label indicates that the Tablets are enteric-coated.The labeling indicates the Drug Release Testwith which the product complies.
Identification— Prepare a test solution by mixing a quantity of finely powdered Tablets with methanol to obtain a concentration of about 2.5mg of erythromycin per mL.Proceed as directed in the Identificationtest under Erythromycin Delayed-Release Capsules,beginning with “Prepare a Standard solution of USP Erythromycin RS.”
Drug release,Method Bá724ñ—
Test 1: If the product complies with this test,the labeling indicates that it meets USPDrug Release Test 1.
Apparatus 1: 100rpm.
Times: 60minutes,Stage 1.
60minutes,Stage 2.
Acid stage— Using 900mLof simulated gastric fluid TS(prepared without pepsin)in place of 0.1Nhydrochloric acid,conduct this stage of the test for 1hour,and do not perform an analysis of the medium.
Buffer stage— Using 900mLof 0.05MpH6.8phosphate buffer (see Buffer Solutionsin the section Reagents,Indicators,and Solutions),conduct this stage of the test for 60minutes.
Test solution— If necessary,dilute a filtered portion of the solution under test with Dissolution Mediumto obtain a solution having a concentration of about 0.28mg of erythromycin per mL,and mix.
Procedure— Transfer a 2.0-mLportion of the Test solutionto a suitable separator.Add 6mLof pH1.2buffer (see Solutionsin the section Reagents,Indicators,and Solutions),and 8mLof a solution of bromocresol purple,prepared by dissolving 1g of bromocresol purple in 1liter of pH4.5phosphate buffer,and mix.Extract with 40.0mLof chloroform.Determine the amount of C37H67NO13dissolved from UVabsorbances at the wavelength of maximum absorbance at about 410nm 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 USPDrug Release Test 2.Proceed as directed under Test 1,except to use Apparatus 2at 75rpm.
Uniformity of dosage units á905ñ: meet the requirements.
Water,Method Iá921ñ: not more than 6.0%,20mLof methanol containing 10%of imidazole being used in place of methanol in the titration vessel.
Assay— Place not less than 4Tablets in a high-speed glass blender jar with 200mLof methanol,and blend for 3minutes.Add 300mLof Buffer No.3,and blend for 3minutes.Proceed as directed under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of this stock test solution diluted quantitatively with Buffer No.3to yield a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 762
Phone Number:1-301-816-8335