Analysis of Polydextrose According to USP-NF Method (SH1011)

According to the United States Pharmacopeia and the National Formulary (USPNF 2025 Issue 1*), "ASSAY" and "Organic Impurities Procedure 2: Limit of Monomers" for "Polydextrose" should be carried out with a column filled with L17 packing material. The SUGAR SH1011, a column filled with L17 packing material, confirmed the requirements were met.

System suitability requirements ASSAY
Relative standard deviation (RSD) (Standard solution): ≤ 2.0%

 

Organic Impurities, Procedure 2: Limit of Monomers
Resolution of adjacent peaks (Standard solution): ≥ 1.0
Relative standard deviation (RSD) (Standard solution): ≤ 5.0%

*The version at the time of the application acquisition.

Sample: 20 µL each
(Standard solution for ASSAY)
4.0 mg/mL of USP Polydextrose RS in eluent

  1. 1.Polydextrose

(Standard solution for Organic Impurities, Procedure 2: Limit of Monomers)
0.08 mg/mL each of USP 1,6-Anhydro-D-glucose RS and USP Sorbitol RS, and 0.16 mg/mL of USP Dextrose RS in eluent

  1. 2.Dextrose
  2. 3.Sorbitol
  3. 4.An isomer of 1,6-Anhydro-D-glucose
  4. 5.1,6-anhydro-D-glucose
chromatgram of polydextrose
Column
：Shodex SUGAR SH-G (6.0 mm I.D. x 50 mm) + SH1011 (8.0 mm I.D. x 300 mm)
Eluent
：0.001 N H2SO4 aq.
Flow rate
：0.5 mL/min
Detector
：RI (35 ℃)
Column temp.
：30 ℃

Sample Name Index

Operation Manual / Certificate of Analysis

Operation Manuals and Certificate of Analysis / Inspection Certificate for the following products can be downloaded here.

Product Name Index

Applications

Applications (Related Information)