Pyrilamine Maleate Tablets

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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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.

USP Reference standards 〈11〉—

USP Pyrilamine Maleate RS

1 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.

2 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:

0.05 C (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.