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.
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solution having a known concentration of USP Oxprenolol Hydrochloride RSin the same medium.[NOTEReplace the aliquots withdrawn for analysis with fresh portions of Dissolution medium.]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:
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
USP28NF23Page 1431
Phone Number:1-301-816-8305
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