Dextrose Excipient

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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C₆H₁₂O₆.H₂O    198.17

D-Glucose, monohydrate;

D-Glucose monohydrate CAS RN®: 77938-63-7.

DEFINITION

Dextrose Excipient is a sugar usually obtained by hydrolysis of starch. It contains 1 molecule of water of hydration. It contains NLT 97.5% and NMT 102.0% of dextrose (C₆H₁₂O₆), calculated on the anhydrous basis.

1 IDENTIFICATION

A. SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197K

Sample: Dry a test specimen per the conditions specified in the test for Water Determination.

Acceptance criteria: Meets the requirements

B.

Analysis: Examine the chromatograms obtained in the Assay.

Acceptance criteria: The principal peak obtained with the Sample solution is similar in retention time and size to the principal peak obtained with Standard solution A.

C. Meets the requirements for the water content in the test for Water Determination.

2 ASSAY

2.1 PROCEDURE

Mobile phase: Water

System suitability solution: 0.1 mg/mL each of USP Maltose Monohydrate RS. USP Maltotriose RS, and USP Fructose RS

Standard solution A: 30 mg/mL of USP Dextrose RS

Sample solution: Equivalent to 30 mg/mL of anhydrous dextrose

2.2 Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: Refractive index

Column: 7.8-mm x 30-cm; 9-um packing 119

Temperatures

Column: 85 ±1°

Detector: 40°

Flow rate: 0.3 mL/min

Injection volume: 20 µL

Run time: 1.5 times the retention time of dextrose

2.3 System suitability

Sample: System suitability solution

[NOTE-The relative retention times for maltotriose, maltose, isomaltose, dextrose, and fructose are 0.7, 0.8, 0.8, 1.0, and 1.3, respectively.

The retention time for dextrose is about 21 min.]

2.4 Suitability requirements

Resolution: NLT 1.3 between maltotriose and maltose

2.5 Analysis

Samples: Standard solution A and Sample solution

Calculate the percentage of dextrose (C₆H₁₂O₆) in the portion of Dextrose Excipient taken:

Result = (r_U/r_S) x (C_S/C_U) × 100

r_U = peak area of dextrose from the Sample solution

r_S = peak area of dextrose from Standard solution A

C_S = concentration of USP Dextrose RS in Standard solution A (mg/mL)

C_U = concentration of Dextrose Excipient in the Sample solution (mg/mL)

Acceptance criteria: 97.5%-102.0% on the anhydrous basis

3 IMPURITIES

RELATED SUBSTANCES

Mobile phase, System suitability solution, and Chromatographic system: Proceed as directed in the Assay.

Standard solution B: Dilute 1.0 mL of the Sample solution with water to 250.0 mL.

Standard solution C: Dilute 25.0 ml. of Standard solution B with water to 200.0 mL

Sample solution: Equivalent to 30 mg/mL of anhydrous dextrose

System suitability

Sample: System suitability solution

[NOTE-The relative retention times for maltotriose, maltose, isomaltose, dextrose, and fructose are 0.7, 0.8, 0.8, 1.0, and 1.3, respectively.

The retention time for dextrose is about 21 min.]

Suitability requirements

Resolution: NLT 1.3 between maltotriose and maltose

Analysis

Samples: Standard solution B, Standard solution C, and Sample solution

The reporting threshold is 0.05%. Disregard any peak with an area less than the principal peak from Standard solution C.

Acceptance criteria

Maltose and isomaltose: NMT 0.6%; the sum is NMT 1.5 times the area of the principal peak from Standard solution B

Maltotriose: NMT 0.2%; NMT 0.5 times the area of the principal peak from Standard solution B

Fructose: NMT 0.15%; NMT 3 times the area of the principal peak from Standard solution C

Unspecified impurities: NMT 0.10%; NMT twice the area of the principal peak from Standard solution C

Total impurities: NMT 0.7%; NMT 1.75 times the area of the principal peak from Standard solution B

RESIDUE ON IGNITION (281): NMT 0.1%

SOLUBLE STARCH, SULFITES

Sample solution: 1 g of Dextrose Excipient in 10 ml of water

Analysis: To the Sample solution add 1 drop of iodine TS.

Acceptance criteria: The liquid is colored yellow.

4 SPECIFIC TESTS

WATER DETERMINATION (921), Method ill

Analysis: Dry under vacuum at 70° to constant weight.

Acceptance criteria: 7.5%-9.5%

COLOR OF SOLUTION

Sample solution: Dissolve 25 g of Dextrose Excipient in water to make 50.0 ml..

Control solution: Mix 1.0 mL of cobaltous chloride CS, 3.0 mL of ferric chloride CS, and 2.0 mL of cupric sulfate CS with water to make 10 mL. Dilute 3 mL of this solution with water to 50 mL.

Analysis: Make the comparison by viewing the Sample solution and Control solution downward in matched color-comparison tubes against a white surface.

Acceptance criteria: The Sample solution has no more color than the Control solution.

ACIDITY

Sample solution: 100 mg/ml. in carbon dioxide-free water

Analysis: Add phenolphthalein TS to 50 mL of the Sample solution, and titrate with 0.020 N sodium hydroxide to the production of a distinct

pink color.

Acceptance criteria: NMT 0.30 mL

CHLORIDE AND SULFATE (221), Chloride

Standard solution: 0.50 mL of 0.020 N hydrochloric acid

Sample: 2.0 g

Acceptance criteria: 0.018%; the Sample shows no more chloride than the Standard solution.

CHLORIDE AND SULFATE (221), Sulfate

Standard solution: 0.50 mL of 0.020 N sulfuric acid

Sample: 2.0 g

Acceptance criteria: 0.025%; the Sample shows no more sulfate than the Standard solution.

Change to read:

ARSINIC (211), Procedures. Procedure 1 (CN 1-JAN-2023): NMT 1 ppm

Dextrin

Sample: 1 g of finely powdered Dextrose Excipient

Analysis: Reflux the Sample with 20 mL of alcohol.

Acceptance criteria: It dissolves completely.

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers.

Labeling: Label it to indicate that it is not intended for parenteral use. Label it to indicate that it is dextrose monohydrate.

USP Reference Standards 〈11〉

USP Dextrose RS

USP Fructose RS

USP Maltose Monohydrate RS

USP Maltotriose RS