ivermectin-compounded-oral-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

Ivermectin Compounded Oral Solution, Veterinary contains NLT 90.0% and NMT 110.0% of the labeled amount of ivermectin, calculated as the sum of components H₂B_1a (C₄₈H₇₄O₁₄) plus H₂B_1b (C₄₇H₇₂O₁₄).

Prepare Ivermectin Compounded Oral Solution, Veterinary 3 mg/mL as follows (see Pharmaceutical Compunding—Nonsterile Preparations

〈795〉).

^a Ivomec Injection 1%, Merial Ltd., Duluth, GA.

Accurately measure the Ivermectin Injection and place into a suitable container. Add sufficient Polyethylene Glycol 400 to bring to final volume. Shake to mix well.

2 ASSAY

Procedure

Mobile phase: Acetonitrile, methanol, and water (45:40:15)

Standard solution: 0.12 mg/mL of USP Ivermectin RS in methanol

Sample solution: Transfer 1 mL of Oral Solution, Veterinary to a 25-mL volumetric flask, and dilute with methanol to volume.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 245 nm

Column: 4.6-mm × 25-cm; 3.6-μm packing L1

Temperatures

Autosampler: 15°

Column: 20°

Flow rate: 1 mL/min

Injection volume: 25 μL

System suitability

Sample: Standard solution

[Note—The retention times for component H₂B_1b and component H₂B_1a are about 23.8 and 31.6 min, respectively.]

Suitability requirements

Resolution: NLT 3.0 between component H₂B_1b and component H₂B_1a

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0% for replicate injections determined from the component H₂B_1a peak

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of ivermectin components H₂B_1a (C₄₈H₇₄O₁₄) plus H₂B_1b (C₄₇H₇₂O₁₄) in the portion of Oral Solution, Veterinary taken:

Result = (r_U/r_S)x(C_S/C_U ) × 100

r_U = peak response of H₂B_1a plus H₂B_1b from the Sample solution

r_S = peak response of H₂B_1a plus H₂B_1b from the Standard solution

C_S = concentration of USP Ivermectin RS in the Standard solution (mg/mL)

C_U = nominal concentration of ivermectin in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

3 SPECIFIC TESTS

pH 〈791〉: 5.6–6.6

4 ADDITIONAL REQUIREMENTS

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

Beyond-Use Date: NMT 90 days after the date on which it was compounded when stored at controlled room temperature.

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

USP Reference Standards 〈11〉

USP Ivermectin RS

2S (USP41)