Tripelennamine Hydrochloride Tablets
»Tripelennamine Hydrochloride Tablets contain not less than 95.0percent and not more than 105.0percent of the labeled amount of C16H21N3·HCl.
Packaging and storage— Preserve in well-closed containers.
Identification— Tablets meet the requirements under Identification—Organic Nitrogenous Bases á181ñ.
Dissolution á711ñ—
Medium: water;900mL.
Apparatus 1: 100rpm.
Time: 45minutes.
Procedure— Determine the amount of C16H21N3·HCl dissolved from UVabsorbances at the wavelength of maximum absorbance at about 306nm of filtered portions of the solution under test,suitably diluted with Dissolution Medium,if necessary,in comparison with a Standard solution having a known concentration of USP Tripelennamine Hydrochloride RSin the same medium.
Tolerances— Not less than 75%(Q)of the labeled amount of C16H21N3·HCl is dissolved in 45minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Assay— Proceed with Tablets as directed under Salts of Organic Nitrogenous Bases á501ñ,determining the absorbance at 313nm.Calculate the quantity,in mg,of C16H21N3·HCl in the portion of Tablets taken by the formula:
50C(AU/AS),
in which Cis the concentration,in mg per mL,calculated on the dried basis,of USP Tripelennamine Hydrochloride RSin the Standard Preparation.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1990
Phone Number:1-301-816-8379
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