Meclofenamate Sodium

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

Meclofenamate Sodium contains NLT 97.0% and NMT 103.0% of meclofenamate sodium (C₁₄H₁₀Cl₂NNaO₂), calculated on the anhydrous basis.

2 IDENTIFICATION

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K

Delete the following:

B. Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy (USP 1-May-2023)

Delete the following:

C. Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy (USP 1-May-2023)

Add the following:

B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. (USP 1-May-2023)

3 ASSAY

Change to read:

Procedure

Solution A: 0.63 g/L of ammonium formate in water. Adjust with formic acid to a pH of 3.0.

Solution B: Acetonitrile

Mobile phase: See Table 1.

Table 1

Diluent: Methanol and water (50:50)

Standard solution: 0.3 mg/mL of USP Meclofenamate Sodium RS in Diluent

Sample solution: 0.3 mg/mL of Meclofenamate Sodium in Diluent

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 270 nm

Column: 4.6-mm × 15-cm; 3.5-μm packing L1

Column temperature: 35°

Flow rate: 0.8 mL/min

Injection volume: 10 μL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 1.10%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of meclofenamate sodium, anhydrous (C₁₄H₁₀Cl₂NNaO₂) in the portion of Meclofenamate Sodium taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of meclofenamate from the Sample solution

r_S = peak response of meclofenamate from the Standard solution

C_S = concentration of USP Meclofenamate Sodium RS in the Standard solution (mg/mL)

C_U= concentration of Meclofenamate Sodium in the Sample solution (mg/mL) (USP 1-May-2023)

Acceptance criteria: 97.0%–103.0% on the anhydrous basis

4 IMPURITIES

Delete the following:

Limit of Copper (USP 1-May-2023)

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Organic Impurities

Solution A, Mobile phase, Diluent, Sample solution, and Chromatographic system: Proceed as directed in the Assay.

Standard solution: 0.3 μg/mL of USP Meclofenamate Sodium RS in Diluent

Sensitivity solution: 0.15 μg/mL of USP Meclofenamate Sodium RS in Diluent from Standard solution

System suitability

Samples: Standard solution and Sensitivity solution

Suitability requirements

Tailing factor: NMT 2.0, Standard solution

Relative standard deviation: NMT 5.0%, Standard solution

Signal-to-noise ratio: NLT 10, Sensitivity solution

Analysis

Samples: Sample solution and Standard solution

Calculate the percentage of any impurity in the portion of Meclofenamate Sodium taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of any impurity from the Sample solution

r_S = peak response of meclofenamate from the Standard solution

C_S = concentration of USP Meclofenamate Sodium RS in the Standard solution (mg/mL)

C_U = concentration of Meclofenamate Sodium in the Sample solution (mg/mL)

Acceptance criteria: See Table 2. The reporting threshold is 0.05%.

Table 2

5 SPECIFIC TESTS

Water Determination 〈921〉, Method I: 4.8%–5.8%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight, light-resistant containers.

USP Reference Standards 〈11〉

USP Meclofenamate Sodium RS