Tramadol Hydrochloride Compounded Oral Suspension, Veterinary

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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1 DEFINITION

Tramadol Hydrochloride Compounded Oral Suspension, Veterinary contains NLT 90.0% and NMT 110.0% of the labeled amount of tramadol hydrochloride (C₁₆H₂₅NO₂ · HCl).

Prepare Tramadol Hydrochloride Compounded Oral Suspension, Veterinary 20 mg/mL as follows (see Pharmaceutical Compounding-Nonsterile Preparations 〈795〉).

ᵃ Perrigo Pharmaceuticals, Allegan, MI.

Add Tramadol Hydrochloride and Sodium Chloride to a suitable mortar, and triturate to a fine powder. Add a small amount of Ora-Blend, and triturate to make a smooth paste. Add increasing volumes of Ora-Blend to make a tramadol hydrochloride liquid that is pourable. Transfer the contents of the mortar, stepwise and quantitatively, to a calibrated bottle. Add enough Ora-Blend to bring to final volume, and mix well. [Note-Sodium Chloride is used to mask bitterness.]

2 ASSAY

2.1 Procedure

Solution A: Dissolve 6.8 g of monobasic potassium phosphate in 1000 mL of water. Add 2.0 g of sodium 1-octanesulfonate, and stir until dissolved. Adjust with phosphoric acid to a pH of 2.0.

Mobile phase: Methanol, acetonitrile, tetrahydrofuran, and Solution A (5:5:15:75)

Standard solution: 0.4 mg/mL of tramadol hydrochloride prepared from USP Tramadol Hydrochloride RS in Solution A

Sample solution: Transfer 1 mL of Oral Suspension, Veterinary into a 50-mL volumetric flask, dilute with Solution A to volume, and mix well.

Chromatographic system

• (See Chromatography 〈621〉, System Suitability.)
• Mode: LC
• Detector: UV 270 nm
• Column: 4.6-mm × 25-cm; 5-µm packing L1
• Flow rate: 1.0 mL/min
• Injection volume: 10 µL

System suitability

• Sample: Standard solution
• [Note-The retention time for tramadol hydrochloride is about 13.4 min.]
• Suitability requirements
• Tailing factor: NMT 2.0
• Relative standard deviation: NMT 2.0% for replicate injections

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of tramadol hydrochloride (C₁₆H₂₅NO₂ · HCl) in the portion of Oral Suspension, Veterinary taken:

Result = (rᵤ/rₛ) × (Cₛ/Cᵤ) × 100

rᵤ = peak response of tramadol hydrochloride from the Sample solution

rₛ = peak response of tramadol hydrochloride from the Standard solution

Cₛ = concentration of tramadol hydrochloride in the Standard solution (mg/mL)

Cᵤ = nominal concentration of tramadol hydrochloride in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

3 SPECIFIC TESTS

pH 〈791〉: 3.4–4.4

4 ADDITIONAL REQUIREMENTS

Packaging and Storage: Package in tight, light-resistant containers. Store at controlled room temperature.

Beyond-Use Date: NMT 180 days after the day on which it was compounded when stored at controlled room temperature

Labeling: Label it to indicate that it is for veterinary use only. Label it to state that it is to be well-shaken before use, and to state the Beyond-Use Date.

USP Reference Standards 〈11〉

USP Tramadol Hydrochloride RS