Ascorbic Acid 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

Ascorbic Acid Compounded Oral Solution contains NLT 90.0% and NMT 110.0% of the labeled amount of ascorbic acid (C₆H₈O₆).

Prepare Ascorbic Acid Compounded Oral Solution, 100 mg/mL, as follows (see Pharmaceutical Compounding-Nonsterile Preparations (795)).

^a Perrigo Laboratories, Allegan, MI.

Place the Ascorbic Acid into a suitable container. Dissolve the powder in the Purified Water. Transfer the contents to a calibrated container. Add sufficient Ora-Sweet to bring to final volume. Shake to mix well.

2 ASSAY

2.1 PROCEDURE

Mobile phase: 50 mM monobasic sodium phosphate; adjusted with phosphoric acid to a pH of 2.5

Standard solution: 0.2 mg/mL of USP Ascorbic Acid RS in Mobile phase

Sample solution: Transfer 0.2 mL of Oral Solution into a 100-mL volumetric flask and dilute with Mobile phase to volume.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 220 nm

Column: 4.6-mm × 25-cm; 5-µm packing L96

Column: 4.6-mm × 25-cm; 5-µm packing L96

Temperatures

Autosampler: 5°

Column: 10°

Flow rate: 1.0 mL/min

Injection volume: 10 µL

System suitability

Sample: Standard solution

[NOTE-The retention time for ascorbic acid is about 4.4 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 ascorbic acid (C₆H₈O₆) in the portion of Oral Solution taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of ascorbic acid from the Sample solution

r_S = peak response of ascorbic acid from the Standard solution

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

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

Acceptance criteria: 90.0%-110.0%

3 SPECIFIC TESTS

PH (791): 1.8-2.8

4 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Package in tight, light-resistant plastic 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 NMT 60 days after the date on which it was compounded when stored at controlled room temperature

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

USP REFERENCE STANDARDS (11).

USP Ascorbic Acid RS