Pyrilamine Maleate Tablets
»Pyrilamine Maleate Tablets contain not less than 93.0percent and not more than 107.0percent of the labeled amount of C17H23N3O·C4H4O4.
Packaging and storage— Preserve in well-closed containers.
Identification— Tablets meet the requirements under Identification—Organic Nitrogenous Bases á181ñ.
Dissolution,Procedure for a Pooled Sample á711ñ—
Medium: water;900mL.
Apparatus 2: 50rpm.
Time: 45minutes.
Procedure— Determine the amount of C17H23N3O·C4H4O4dissolved,employing the procedure set forth in the Assay,making any necessary modifications.
Tolerances— Not less than 75%(Q)of the labeled amount of C17H23N3O·C4H4O4is 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 the wavelength of maximum absorbance at about 312nm.Calculate the quantity,in mg,of C17H23N3O·C4H4O4in the portion of Tablets taken by the formula:
0.05C(AU/AS),
in which Cis the concentration,in µg per mL,calculated on the dried basis,of USP Pyrilamine Maleate RSin the Standard Preparation.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1686
Pharmacopeial Forum:Volume No.30(1)Page 177
Phone Number:1-301-816-8379