Vancomycin Hydrochloride Compounded Oral Solution

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

DOWNLOAD PDF HERE

1 DEFINITION

Vancomycin Hydrochloride Compounded Oral Solution contains NLT 90.0% and NMT 110.0% of the labeled amount of vancomycin (C₆₆H₇₅Cl₂N₉O₂₄).

Prepare Vancomycin Hydrochloride Compounded Oral Solution 50 mg/mL as follows (see Pharmaceutical Compounding-Nonsterile Preparations 〈795〉).

ᵃ Calculate the amount of vancomycin hydrochloride needed based on the potency equivalent (activity) of vancomycin.

ᵇ Fagron Inc., St. Paul, MN.

Calculate the amount of Vancomycin Hydrochloride needed based on the potency equivalent (activity) of vancomycin. Pour the Vancomycin Hydrochloride into a suitable container. Wet the powder with a small amount of SyrSpend SF PH4 (Liquid Cherry Flavored) and triturate to make a smooth paste. Add the SyrSpend SF PH4 (Liquid Cherry Flavored) to make the contents pourable. Transfer the contents stepwise and quantitatively to a calibrated container using the remainder of the SyrSpend SF PH4 (Liquid Cherry Flavored). Add sufficient SyrSpend SF PH4 (Liquid Cherry Flavored) to bring to final volume. Shake to mix well.

2 ASSAY

2.1 Procedure

Solution A: 50 mM ammonium acetate adjusted with ammonium hydroxide to a pH of 8.0

Solution B: Methanol and water (35:65)

Mobile phase: See Table 1.

Table 1

Standard solution: 0.5 mg/mL of vancomycin B prepared from USP Vancomycin B RS in water

Sample solution: Transfer 1 mL of Oral Solution to a 100-mL volumetric flask and dilute with water to volume.

Chromatographic system

• (See Chromatography 〈621〉, System Suitability.)
• Mode: LC
• Detector: UV 280 nm
• Column: 2.1-mm × 15-cm; 5-µm packing L1
• Column temperature: 40°
• Flow rate: 0.2 mL/min
• Injection volume: 10 µL

System suitability

• Sample: Standard solution
• [Note-The retention time for vancomycin B is about 14.8 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 vancomycin (C₆₆H₇₅Cl₂N₉O₂₄) in the portion of Oral Solution taken:

Result = (rᵤ/rₛ) × (Cₛ/Cᵤ) × 100

rᵤ = peak response of vancomycin from the Sample solution

rₛ = peak response of vancomycin B from the Standard solution

Cₛ = concentration of vancomycin B in the Standard solution (mg/mL)

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

Acceptance criteria: 90.0%–110.0%

3 SPECIFIC TESTS

pH 〈791〉: 2.5–3.5

4 ADDITIONAL REQUIREMENTS

Packaging and Storage: Package in tight, light-resistant plastic containers. Store in a refrigerator.

Beyond-Use Date: NMT 60 days after the date on which it was compounded when stored in a refrigerator.

Labeling: Label it to state the Beyond-Use Date.

USP Reference Standards 〈11〉

USP Vancomycin B RS