Sodium Chloride 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

Sodium Chloride Tablets contain NLT 95.0% and NMT 105.0% of the labeled amount of sodium chloride (NaCl).

2 IDENTIFICATION

Change to read:

A. (USP 1-May-2021) Identification Tests—General 〈191〉, Chemical Identification Tests, Sodium

Sample solution: A filtered extract of Tablets

Acceptance criteria: Meet the requirements

Change to read:

B. The retention time of the chloride peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

(USP 1-May-2021)

3 ASSAY

Change to read:

Procedure

Use water with a resistivity of NLT 18 megohm-cm to prepare the solutions.

Solution A: 100 mM potassium hydroxide

Solution B: Water

Mobile phase: See Table 1. [Note—Alternatively, Mobile phase can be generated electrolytically using an automatic eluant generator.]

Table 1

System suitability solution: 100 μg/mL of USP Sodium Chloride RS and 8 μg/mL of USP Sodium Nitrite RS in water

Standard solution: 100 μg/mL of USP Sodium Chloride RS in water

Sample stock solution: Nominally 5 mg/mL of sodium chloride prepared as follows. Finely powder NLT 30 Tablets and transfer an appropriate portion of the powder to a suitable volumetric flask. Dissolve in about 50% of the final volume of water. Dilute with water to volume.

Sample solution: Nominally 100 μg/mL of sodium chloride in water from the Sample stock solution

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: Conductivity with suppression

Columns

Guard: 4.0-mm × 5-cm; 11-μm packing L121. [Note—Alternatively, a 4.0-mm × 0.5-cm; 5.0-μm packing L91 column may be used.]

Analytical: 4.0-mm × 25-cm; 7.5-μm packing L103. [Note—Alternatively, a 4.0-mm × 15-cm; 5.0-μm packing L91 column may be used.]

Column temperature: 35°

Flow rate: 1.2 mL/min

Injection volume: 10 μL

System suitability

Samples: System suitability solution and Standard solution

[Note—The relative retention times for the chloride and nitrite peaks are 1.0 and 1.1, respectively.]

Suitability requirements

Resolution: NLT 2.0 between the chloride and nitrite peaks, System suitability solution

Tailing factor: NMT 2.0 for the chloride and nitrite peaks, System suitability solution

Relative standard deviation: NMT 2.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of sodium chloride (NaCl) in the portion of Tablets taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of chloride from the Sample solution

r_S = peak response of chloride from the Standard solution

C_S = concentration of USP Sodium Chloride RS in the Standard solution (μg/mL)

C_U = nominal concentration of sodium chloride in the Sample solution (μg/mL)

Acceptance criteria: 95.0%–105.0% (USP 1-May-2021)

4 PERFORMANCE TESTS

Disintegration 〈701〉

Time: 30 min

Acceptance criteria: Meet the requirements

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 IMPURITIES

Iodide or Bromide

Sample: 2.0 g of powdered Tablets

Sample solution: Digest the Sample with 25 mL of warm alcohol for 3 h, cool, and filter. Use the filtrate.

Analysis: Evaporate the Sample solution to dryness, dissolve the residue in 5 mL of water, filter if necessary, and add 1 mL of chloroform.

Cautiously introduce, dropwise and with constant agitation, 5 drops of 33% (v/v) chlorine TS in water.

Acceptance criteria: The chloroform does not acquire a violet, yellow, or orange color.

Barium

Sample: 4.0 g of powdered Tablets

Sample solution: Digest the Sample with 20 mL of water, and filter. Use the filtrate.

Analysis: Divide the Sample solution into two equal portions. To one portion add 2 mL of 2 N sulfuric acid and to the other portion add 2 mL of water, and stand for 2 h.

Acceptance criteria: The solutions are equally clear.

Calcium and Magnesium

Sample: 1 g of powdered Tablets

Sample solution: Digest the Sample with 50 mL of water, and filter. Use the filtrate.

Analysis: Add 4 mL of 6 N ammonium hydroxide to the Sample solution, and divide the mixture into two equal portions. Treat one portion with 1 mL of ammonium oxalate TS and the other portion with 1 mL of dibasic sodium phosphate TS.

Acceptance criteria: Neither mixture becomes turbid within 5 min.

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers.

Add the following:

USP Reference Standards 〈11〉

USP Sodium Chloride RS

USP Sodium Nitrite RS (USP 1-May-2021)