water; 900 mL.
Determine the amount of C16
·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.
Not less than 75% (Q) of the labeled amount of C16H21N3·HCl is dissolved in 45 minutes.
Proceed with Tablets as directed under Salts of Organic Nitrogenous Bases 501
, determining the absorbance at 313 nm. Calculate the quantity, in mg, of C16
·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.