Dextrates

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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CAS RN^®: 39404-33-6. (NF 1-May-2023)

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1 DEFINITION

Dextrates is a purified mixture of saccharides resulting from the controlled enzymatic hydrolysis or acid hydrolysis (NF 1-May-2023) of corn, potato, or tapioca (NF 1-May-2023) starch. It is either anhydrous or hydrated. Its dextrose equivalent is NLT 93.0% and NMT 99.0% (NF 1-May-2023)

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2 IDENTIFICATION

A. SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197K. Perform the test for Hydrated Dextrates only. Use the undried sample and USP Dextrates Monohydrate RS.

B. MELTING RANGE OR TEMPERATURE (741): 138°-146° (NF 1-May-2023)

3 ASSAY

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DEXTROSE EQUIVALENT

Mobile phase: Water

Standard solution A: Prepare a solution in Mobile phase, containing 2% dextrose and 1.5% maltose, using USP Dextrose RS and USP Maltose Monohydrate RS.

Standard solution B: Prepare a solution in Mobile phase, containing a total of 5% of USP Dextrates Monohydrate RS.

Sample solution: 5% of Dextrates in Mobile phase

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: Refractive index

Column: 7.8-mm x 30-cm analytical; 25-µm packing L124¹

Temperatures

Column: 85°

Detector: 40°

[NOTE-Column and detector temperatures (± 1°) will help to achieve System suitability requirements.]

Flow rate: 0.5 mL/min

Injection volume: 20 µL

Run time: 30 min

System suitability

Samples: Standard solution A and Standard solution B

Suitability requirements

Resolution: NLT 1.5 between dextrose and maltose peaks in Standard solution A; NLT 1.3 between dextrose and maltose in Standard solution B

Analysis

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

Identify each saccharide peak in the Sample solution based on that in Standard solution A and Standard solution B.

Calculate the percentage of each saccharide in the portion of Dextrates taken:

% Area = (r_A/r_B) x 100

r_A = peak response of each saccharide degree of polymerization (DP₁-DP₃) in the Sample solution (If any peaks of DP₄ and above are observed in the sample, take the summation of all peak responses DP₄₊ and use this value as r_A (ERR 1-May-2023))

r_B = sum of all peak responses excluding peak responses due to solvent from the Sample solution

The expected dextrose equivalent (DE) values for each component are listed in Table 1.

Table 1

[NOTE-Due to the fact that the HPLC analysis cannot further distinguish oligosaccharides greater than DP₄, and the naturally low amount of the higher order oligosaccharides present in the sample, the value for DP₄₊ was estimated as the average of the expected DE values for DP₄ and above.] 

Calculate the dextrose equivalent (DE):

DE = Σ[(Expected DE)_DPx x (% Area/100)_DPx

Expected DE = defined in Table 1

% Area = calculated above (NF 1-May-2023)

Acceptance criteria: NLT 93.0% and NMT 99.0% (NF 1-May-2023)

4 IMPURITIES

RESIDUE ON IGNITION (281): NMT 0.1%

5 SPECIFIC TESTS

5.1 PH (791)

Sample: 200 mg/mL in carbon dioxide-free water

Acceptance criteria: 3.8-5.8

5.2 LOSS ON DRYING (731)

Analysis: Dry at 105° for 16 h in a convection oven.

Acceptance criteria: For the anhydrous form, NMT 2.0%; for the hydrated form, 7.8%-9.2%

6 ADDITIONAL REQUIREMENTS

6.1 PACKAGING AND STORAGE

Preserve in well-closed containers, and store in a cool, dry place.

6.2 LABELING

Label it to state whether it is anhydrous or hydrated.

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6.3 USP REFERENCE STANDARDS (11)

USP Dextrose RS

USP Dextrates Monohydrate RS

USP Maltose Monohydrate RSA (NF 1-May-2023)

¹ A suitable column is Aminex HPX-42A from www.bio-rad.com.