Valine 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)

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1 DEFINITION

Valine Compounded Oral Solution contains NLT 90.0% and NMT 110.0% of the labeled amount of valine (C₅H₁₁NO₂).

Prepare Valine Compounded Oral Solution 10 mg/mL as follows (see Pharmaceutical Compounding-Nonsterile Preparations 〈795〉).

In an appropriately sized container, add Methylparaben and Propylparaben to about 80 mL of Purified Water. Stir until dissolved. [Note-May heat up to 50° to facilitate dissolution.] Dissolve the Valine in the previously prepared solution of Methylparaben and Propylparaben and bring to final volume with Purified Water.

2 ASSAY

2.1 Procedure

Solution A: 6.8 g/L of potassium phosphate monobasic in water. Filter.

Mobile phase: Acetonitrile and Solution A (65:35). Filter.

Diluent: Acetonitrile and Solution A (50:50)

Standard solution: 1 mg/mL of USP l-Valine RS in Diluent

Sample solution: Transfer 1 mL of Oral Solution into a 10-mL volumetric flask, dilute with Diluent to volume, and mix.

Chromatographic system

• (See Chromatography 〈621〉, System Suitability.)
• Mode: LC
• Detector: UV 210 nm
• Column: 4.6-mm × 25-cm; 5-µm packing L8
• Flow rate: 1.0 mL/min
• Injection volume: 10 µL

System suitability

• Sample: Standard solution
• [Note-The retention time for valine is about 8.9 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 valine (C₅H₁₁NO₂) in the portion of Oral Solution taken:

Result = (rᵤ/rₛ) × (Cₛ/Cᵤ) × 100

rᵤ = peak response of valine from the Sample solution

rₛ = peak response of valine from the Standard solution

Cₛ = concentration of USP l-Valine RS in the Standard solution (mg/mL)

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

Acceptance criteria: 90.0%–110.0%

3 SPECIFIC TESTS

pH 〈791〉: 5.7–6.7

4 ADDITIONAL REQUIREMENTS

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

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

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

USP Reference Standards 〈11〉

USP l-Valine RS