Oxprenolol Hydrochloride Extended-Release Tablets
»Oxprenolol Hydrochloride Extended-Release Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of oxprenolol hydrochloride (C15H23NO3·HCl).
Packaging and storage— Preserve in well-closed,light-resistant containers.
Identification— Tablets respond to the Identificationtest under Oxprenolol Hydrochloride Tablets.
Drug release á724ñ—
Acid medium: 0.1Nhydrochloric acid;900mL.
Dissolution medium: simulated intestinal fluid TS(without enzyme);900mL.
Apparatus 1: 100rpm.
Times: 1hour in Acid medium;1,3,and 7hours in Dissolution medium.
Procedure— Determine the amount of C15H23NO3·HCl dissolved from UVabsorbances at the wavelength of maximum absorption at about 272nm of the first solution under test,suitably diluted with Acid medium,in comparison with a Standard solution having a known concentration of USP Oxprenolol Hydrochloride RSin the same medium.Promptly transfer the basket containing the Tablet to Dissolution medium.After 1,3,and 7hours,respectively,remove 9.0mLof the test solution and determine the amount of C15H23NO3·HCl dissolved from UVabsorbances at the wavelength of maximum absorption at about 272nm of the solution under test,suitably diluted with Dissolution medium,in comparison with a Standard solution having a known concentration of USP Oxprenolol Hydrochloride RSin the same medium.[NOTE—Replace the aliquots withdrawn for analysis with fresh portions of Dissolution medium.]
Tolerances— The percentages of the labeled amount of C15H23NO3·HCl dissolved at the times specified conform to Acceptance Table 1:
Time (hours) Amount dissolved
1,in Acid medium between 15%and 45%
1,in Dissolution medium between 30%and 60%
3,in Dissolution medium between 50%and 80%
7,in Dissolution medium not less than 75%
Uniformity of dosage units á905ñ: meet the requirements.
Procedure for content uniformity— Proceed as directed for Procedure for the content uniformityin the test for Uniformity of dosage unitsunder Oxprenolol Tablets.
Assay— Determine the mean value of the C15H23NO3·HCl contents of the Tablets tested as directed under Uniformity of dosage units.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 1431
Phone Number:1-301-816-8305
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