Dissolution 711
Medium:
water; 900 mL.
Apparatus 1:
100 rpm.
Time:
45 minutes.
Procedure
Determine the amount of C
16H
21N
3·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.
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 C
16H
21N
3·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.