Folic 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

Folic Acid Compounded Oral Solution contains NLT 90.0% and NMT 110.0% of the labeled amount of folic acid (C₁₉H₁₉N₇O₆).

Prepare Folic Acid Compounded Oral Solution, 1 mg/mL, as follows (see Pharmaceutical Compounding-Nonsterile Preparations (795)).

Dissolve the Sodium Bicarbonate in 60 mL of Purified Water followed by the Folic Acid. Add the Glycerin to the mixture. Mix well. Add sufficient Purified Water to bring to final volume.

2 ASSAY

2.1 PROCEDURE

Solution A: 50 mM monobasic potassium phosphate adjusted with phosphoric acid to a pH of 2.5

Mobile phase: See Table 1.

Table 1

Diluent: 0.01 N sodium hydroxide

Standard solution: 0.2 mg/mL of USP Folic Acid RS in Diluent

Sample solution: Transfer 1.0 mL of Oral Solution to a 5-mL volumetric flask and add Diluent to volume.

2.2 Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 280 nm

Column: 4.6-mm × 10-cm; 2.6-µm packing L1

Column temperature: 40°

Flow rate: 1.0 mL/min

Injection volume: 5 µL

2.3 System suitability

Sample: Standard solution

[NOTE-The retention time for folic acid is about 21.4 min.]

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0% for replicate injections

2.4 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of folic acid (C₁₉H₁₉N₇O₆) in the portion of Oral Solution taken:

Result = (r_U/r_S) x (C_S/C_U) x 100

r_U = peak response of folic acid from the Sample solution

r_S = peak response of folic acid from the Standard solution

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

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

Acceptance criteria: 90.0%-110.0%

3 SPECIFIC TESTS

PH (791): 7.8-8.8

4 ADDITIONAL REQUIREMENTS

4.1 PACKAGING AND STORAGE

Package in tight, light-resistant plastic containers. Store in a refrigerator or at controlled room temperature.

4.2 BEYOND-USE DATE

NMT 60 days after the date on which it was compounded when stored in a refrigerator or at controlled room temperature.

4.3 LABELING

Label it to state the Beyond-Use Date.

4.4 USP REFERENCE STANDARDS (11)

USP Folic Acid RS