Guaifenesin Compounded Injection, 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

Guaifenesin Compounded Injection, Veterinary contains NLT 90.0% and NMT 110.0% of the labeled amount of guaifenesin (C₁₀H₁₄O₄).

Prepare Guaifenesin Compounded Injection, Veterinary 50 mg/mL as follows (see Pharmaceutical Compounding - Sterile Preparations 〈797〉.)

Accurately weigh the Guaifenesin and transfer it into a sterile depyrogenated beaker. Add the Propylene Glycol to the Guaifenesin and mix well to wet. Add about 200 mL of the Dextrose Injection (5%) to the guaifenesin mixture and heat the mixture briefly, not to exceed 50°, for solubilization. Bring to final volume with the Dextrose Injection (5%). Pass through an inline sterile membrane filter of 0.22-μm pore size into a sterile polyvinyl chloride intravenous bag. [Note - Use a sterilizing filter that is compatible with glycol-containing solutions.]

2 ASSAY

2.1 Procedure

Solution A: Dissolve 2.5 mL of glacial acetic acid in 1000 mL of water.

Mobile phase: Methanol and Solution A (35:65)

Diluent: Methanol and water (35:65)

Standard solution: 1 mg/mL of guaifenesin prepared from USP Guaifenesin RS in Diluent

Sample solution: Transfer 1 mL of Injection, Veterinary into a 50-mL volumetric flask, dilute with Diluent to volume, and mix well to dissolve.

2.2 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 276 nm

Column: 4.6-mm × 25-cm; 5-μm packing L1

Column temperature: 25°

Flow rate: 1.0 mL/min

Injection volume: 15 μL

2.3 System suitability

Sample: Standard solution

[Note - The retention time for guaifenesin is about 16.4 min.]

2.4 Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0% for replicate injections

2.5 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of guaifenesin (C₁₀H₁₄O₄) in the portion of Injection, Veterinary taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of guaifenesin from the Sample solution

r_S = peak response of guaifenesin from the Standard solution

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

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

Acceptance criteria: 90.0%–110.0%

3 SPECIFIC TESTS

pH 〈791〉: 3.6–4.6

Sterility Tests 〈71〉, Test for Sterility of the Product to Be Examined, Membrane Filtration: It meets the requirements.

Bacterial Endotoxins Test 〈85〉: NMT 0.05 USP Endotoxin Units/mg of guaifenesin

Particulate Matter in Injections 〈788〉: It meets the requirements.

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4 ADDITIONAL REQUIREMENTS

Packaging and Storage: Package in a sterile polyvinyl chloride intravenous bag. Store at controlled room temperature or at 37°. [Note - Do not store at cold temperatures as precipitation may occur.]

Beyond-Use Date: In the absence of passing a sterility and endotoxins test, the beyond-use dates (BUDs) in Pharmaceutical Compounding—

Sterile Preparations 〈797〉 apply. After successful completion of sterility and endotoxins testing, NMT 90 days after the date on which it was compounded when stored at controlled room temperature or NMT 7 days after the date on which it was compounded when stored at 37°. (CN 1-May-2020)

Labeling: Label it to indicate that it is for veterinary use only. The label states that it is intended for injection only by the intravenous route.

Label it to state the Beyond-Use Date.

USP Reference Standards 〈11〉

USP Guaifenesin RS