Docusate Sodium Tablets

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

Docusate sodium Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of docusate sodium (C₂₀H₃₇NaO₇S).

2 IDENTIFICATION

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A. SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197K _{(CN 1-MAY-2020)}

Sample: Finely divide a suitable number of Tablets, extract with solvent hexane, filter, and evaporate the solvent hexane extract on a steam bath. Use the dry residue.

Acceptance criteria: Meet the requirements

3 ASSAY

PROCEDURE

Mobile phase: Acetonitrile and 7 mM ammonium acetate (1:1)

Standard solution: Dissolve the USP Docusate Sodium RS in alcohol, and dilute with water to obtain a solution containing 1.0 mg/mL of USP

Docusate Sodium RS.

Methylparaben solution: 0.15 mg/mL of methylparaben in water

System suitability solution: Mix 0.1 mL of Methylparaben solution and 10 mL of Standard solution.

Sample solution: Transfer 10 Tablets to a 1-L volumetric flask, add 200 mL of alcohol and 300 mL of water, and shake by mechanical means for NLT 90 min to completely disintegrate the Tablets. Dilute with water to volume, and filter, discarding the first 3 mL of the filtrate.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 210 nm

Column: 4.6-mm x 10-cm; packing L1

Column temperature: 40^o

Flow rate: 1 mL/min

Injection volume: 40 µL

System suitability

Samples: Standard solution and System suitability solution

[NOTE-The relative retention times for methylparaben and docusate are about 0.74 and 1.0, respectively.]

Suitability requirements

Resolution: NLT 2.0 between methylparaben and docusate, System suitability solution

Tailing factor: NMT 2.5, Standard solution

Relative standard deviation: NMT 1.8%, Standard solution.

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of docusate sodium (C₂₀H₃₇NaO₇S) in the portion of Tablets taken:

Result = (r_u /r_s ) × (C_s /C_u ) × 100

r_u = peak response from the Sample solution

r_s = peak response from the Standard solution

C_s = concentration of USP Docusate Sodium RS in the Standard solution (mg/mL)

C_u = nominal concentration of docusate sodium in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Disintegration 〈701〉

Medium: Proceed as directed in the chapter, except substitute simulated gastric uid TS for water in the test for Uncoated Tablets.

Time: 1 h

Acceptance criteria: Meet the requirements

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers.

USP Reference Standards 〈11〉

USP Docusate Sodium RS