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Tripelennamine Hydrochloride Tablets
» Tripelennamine Hydrochloride Tablets contain not less than 95.0 percent and not more than 105.0 percent 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 181.
Dissolution 711
Medium: water; 900 mL.
Apparatus 1: 100 rpm.
Time: 45 minutes.
Procedure— Determine the amount of C16H21N3·HCl dissolved from UV absorbances at the wavelength of maximum absorbance at about 306 nm 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 RS in the same medium.
Tolerances— Not less than 75% (Q) of the labeled amount of C16H21N3·HCl is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Assay— Proceed with Tablets as directed under Salts of Organic Nitrogenous Bases 501, determining the absorbance at 313 nm. Calculate the quantity, in mg, of C16H21N3·HCl in the portion of Tablets taken by the formula:
50C(AU / AS),
in which C is the concentration, in mg per mL, calculated on the dried basis, of USP Tripelennamine Hydrochloride RS in the Standard Preparation.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 2215
Phone Number : 1-301-816-8143