Buprenorphine Compounded Buccal Solution, 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

Buprenorphine Compounded Buccal Solution, Veterinary, contains NLT 90.0% and NMT 110.0% of the labeled amount of buprenorphine (C₂₉H₄₁NO₄).

Prepare Buprenorphine Compounded Buccal Solution, Veterinary 3 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉).

Buprenorphine (as hydrochloride) 30 mg (32.4 mg)

Dextrose 500 mg

Sodium Citrate (anhydrous) 20 mg

Citric Acid Monohydrate 25 mg

Purified Water, a sufficient quantity to make 10 mL

Dissolve the Dextrose, Sodium Citrate Anhydrous, and Citric Acid Monohydrate in 5 mL of Purified Water in a suitable calibrated container. Add the Buprenorphine hydrochloride powder into the mixture and add sufficient Purified Water to bring to final volume, and mix well.

2 ASSAY

Procedure

Mobile phase: Acetonitrile and 10 mM ammonium acetate (80:20)

Standard solution: 0.3 mg/mL of buprenorphine prepared from USP Buprenorphine Hydrochloride RS in methanol

Sample solution: Transfer 1 mL of Buccal Solution, Veterinary into a 10-mL volumetric flask, dilute with methanol to volume, and mix well.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 280 nm

Column: 2.1-mm × 5-cm; 5-µm packing L7

Column temperature: 40°

Flow rate: 0.25 mL/min

Injection volume: 10 µL

System suitability

Sample: Standard solution

[Note—The retention time for buprenorphine is about 5.8 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 buprenorphine (C₂₉H₄₁NO₄) in the portion of Buccal Solution, Veterinary taken:

Result = (r₁/r₂) × (C₁/C₂) × 100

r₁ = peak response of buprenorphine from the Sample solution

r₂ = peak response of buprenorphine from the Standard solution

C₁ = concentration of buprenorphine in the Standard solution (mg/mL)

C₂ = nominal concentration of buprenorphine in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

3 SPECIFIC TESTS

pH 〈791〉: 3.5–4.5

4 ADDITIONAL REQUIREMENTS

Packaging and Storage: Package in tight, light-resistant containers. Store at 2°–8°.

Labeling: Label it to indicate that it is for veterinary use only. Label to indicate that it is for buccal administration, and to state the Beyond-Use Date.

Beyond-Use Date: NMT 90 days after the date on which it was compounded when stored at 2°–8°

USP Reference Standards 〈11〉

USP Buprenorphine Hydrochloride RS