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Pyrilamine Maleate Tablets
» Pyrilamine Maleate Tablets contain not less than 93.0 percent and not more than 107.0 percent 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 181.
Dissolution, Procedure for a Pooled Sample 711—
Medium: water; 900 mL.
Apparatus 2: 50 rpm.
Time: 45 minutes.
Procedure— Determine the amount of C17H23N3O·C4H4O4 dissolved, employing the procedure set forth in the Assay, making any necessary modifications.
Tolerances— Not less than 75% (Q) of the labeled amount of C17H23N3O·C4H4O4 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 the wavelength of maximum absorbance at about 312 nm. Calculate the quantity, in mg, of C17H23N3O·C4H4O4 in the portion of Tablets taken by the formula:
0.05C(AU / AS),
in which C is the concentration, in µg per mL, calculated on the dried basis, of USP Pyrilamine Maleate 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 1872
Pharmacopeial Forum : Volume No. 30(1) Page 177
Phone Number : 1-301-816-8143