Tripelennamine Hydrochloride 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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» Tripelennamine Hydrochloride Tablets contain not less than 95.0 percent and not more than 105.0 percent of the labeled amount of C₁₆H₂₁N₃ · HCI.

1 Packaging and storage-

Preserve in well-closed containers.

2 USP REFERENCE STANDARDS (11)-

USP Trigelennamine Hydrochloride RS

Identification-Tablets meet the requirements under Identification-Organic Nitrogenous Bases (181)

2.1 DISSOLUTION (711)-

Medium: water, 900 mL.

Apparatus 1: 100 rpm.

Time: 45 minutes.

Procedure-Determine the amount of C₁₆H₂₁N₃ · HCI 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 · HCI is dissolved in 45 minutes.

UNIFORMITY OF DOSAGE UNITS (905): meet the requirements.

2.2 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 C₁₆H₂₁N₃ · HCI in the portion of Tablets taken by the formula:

                       50C(A_U/A_S)

in which C is the concentration, in mg per ml, calculated on the dried basis, of USP Tripelennamine Hydrochloride RS in the Standard Preparation.