Sodium Gluconate

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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d-Gluconic acid, monosodium salt;

Monosodium d-gluconate CAS RN®: 527-07-1; UNII: R6Q3791S76.

1 DEFINITION

Sodium Gluconate contains NLT 98.0% and NMT 102.0% of sodium gluconate (C₆H₁₁NaO₇).

2 IDENTIFICATION

A. Identification Tests—General 〈191〉, Chemical Identification Tests, Sodium

Sample solution: 1 in 20

Acceptance criteria: Meets the requirements

B. Thin-Layer Chromatography

Standard solution: 10 mg/mL of USP Potassium Gluconate RS in water. [Note—Heat in a water bath at 60° to dissolve, if necessary.]

Sample solution: 10 mg/mL of Sodium Gluconate in water. [Note—Heat in a water bath at 60° to dissolve, if necessary.]

Chromatographic system

(See Chromatography 〈621〉, Thin-Layer Chromatography.)

Mode: TLC

Adsorbent: 0.25-mm layer of chromatographic silica gel

Application volume: 5 μL

Developing solvent system: Alcohol, ethyl acetate, ammonium hydroxide, and water (50:10:10:30)

Spray reagent: Dissolve 2.5 g of ammonium molybdate in 50 mL of 2 N sulfuric acid in a 100-mL volumetric flask, add 1.0 g of ceric sulfate, swirl to dissolve, and dilute with 2 N sulfuric acid to volume.

Analysis

Samples: Standard solution and Sample solution

Develop in the Developing solvent system until the solvent front has moved three-fourths of the length of the plate. Remove the plate from the chamber, and dry at 110° for 20 min. Allow to cool and spray with the Spray reagent. Heat the plate at 110° for 10 min.

Acceptance criteria: The color, size, and R value of the principal spot from the Sample solution corresponds to that from the Standardsolution.

3 ASSAY

Procedure

Sample: 150 mg

Analysis: Transfer the Sample to a suitable conical flask and dissolve in 75 mL of glacial acetic acid, warming to dissolve, if necessary. Cool, add quinaldine red TS, and titrate with 0.1 N perchloric acid VS to a colorless endpoint. Each milliliter of 0.1 N perchloric acid is equivalent. to 21.81 mg of sodium gluconate (C₆H₁₁NaO₇ ).

Acceptance criteria: 98.0%–102.0%

4 IMPURITIES

Change to read:

Chloride and Sulfate 〈221〉, Chloride

Sample: 1.0 g

Acceptance criteria: The turbidity produced in the Sample does not exceed that produced in (USP 1-May-2022) 1 mL of 0.02 N hydrochloric acid (NMT 0.07%).

Change to read:

Chloride and Sulfate 〈221〉, Sulfate

Sample: 2.0 g, dissolved in boiling water

Acceptance criteria: The turbidity produced in the Sample does not exceed that produced in (USP 1-May-2022) 1 mL of 0.020 N sulfuric acid (NMT 0.05%).

Delete the following:

Lead 〈251〉

Test preparation: 1.0 g in 25 mL of water

Acceptance criteria: NMT 10 ppm (USP 1-May-2022)

Reducing Substances

Sample: 1.0 g

Analysis: Transfer the Sample to a 250-mL conical flask, dissolve in 10 mL of water, and add 25 mL of alkaline cupric citrate TS. Cover the flask; boil gently for 5 min, accurately timed; and cool rapidly to room temperature. Add 25 mL of 0.6 N acetic acid, 10.0 mL of 0.1 N iodine VS, and 10 mL of 3 N hydrochloric acid, and then titrate with 0.1 N sodium thiosulfate VS, adding 3 mL of starch TS as the endpoint is approached. Perform a blank determination, omitting the specimen, and note the difference in volumes required (see Titrimetry 〈541〉). Each milliliter of the difference in volume of 0.1 N sodium thiosulfate consumed is equivalent to 2.7 mg of reducing substances (as dextrose).

Acceptance criteria: NMT 0.5%

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers.

USP Reference Standards 〈11〉

USP Potassium Gluconate RS