Tripelennamine Hydrochloride Injection

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 Injection is a sterile solution of Tripelennamine Hydrochloride in Water for Injection. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of tripelennamine hydrochloride (C₁₆H₂₁N₃ · HCI).

1 Packaging and storage-

Preserve in tight, single-dose or multiple-dose containers as described in Packaging and Storage Requirements (659). Injection Packaging. Store at a controlled room temperature, and protect from light.

2 Labeling-

Label it to indicate that it is for veterinary use only.

3 USP REFERENCE STANDARDS (11)-

USP Tripelennamine Hydrochloride RS

3.1 Identification-

A: Identification-Organic Nitrogenous Bases (181).

B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.

BACTERIAL ENDOTOXINS TEST (85)-It contains not more than 4.6 USP Endotoxin Units per mg of tripelennamine hydrochloride.

STERILITY TESTS (71).-It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.

pH (791): between 6.0 and 7.0.

PARTICULATE MATTER IN INJECTIONS (788): meets the requirements for small-volume injections.

3.2 Other requirements-

It meets the requirements under Injections and Implanted Drug Products (1)

3.3 Assay-

Mobile phase-Dissolve 4.8 g of monobasic potassium phosphate in 880 mL of water in a 2-liter cylinder. Add 720 mL of methanol and 400 mL of acetonitrile, mix, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography (621)).

Standard preparation-Dissolve an accurately weighed quantity of USP Tripelennamine Hydrochloride RS quantitatively in water to obtain a solution having a known concentration of about 0.02 mg per mL. Protect this solution from light.

Assay preparation-Transfer an accurately measured volume of Injection, equivalent to about 4 mg of tripelennamine hydrochloride, to a 200-mL volumetric flask, dilute with water to volume, and mix.

Chromatographic system (see CHROMATOGRAPHY (621))-The liquid chromatograph is equipped with a 254-nm detector, a 3.9 - mm x 30 - mm guard column that contains packing L1, and a 3.9-mm x 30-cm analytical column that contains packing L1. The flow rate is about 1 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the relative standard deviation for replicate injections is not more than 2.0%.

Procedure-Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the tripelennamine peaks, Calculate the quantity, in mg, of tripelennamine hydrochloride (C₁₆H₂₁N₃ · HCI) in each mL of the Injection taken by the formula:

                       200(C/V)(r_U/r_S)

in which C is the concentration, in mg per mL, of USP Tripelennamine Hydrochloride RS in the Standard preparation; V is the volume, in ml, of Injection taken to prepare the Assay preparation; and r_U and r_S are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.