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Updated: Feb 11, 2026
09:13
Characterization of Ultra-fine Grained and Nanocrystalline Materials Using Transmission Kikuchi Diffraction
Published on: April 1, 2017
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Fine structural characterization of sulodexide.
Noemi Veraldi1, Marco Guerrini1, Elena Urso1
1Istituto di Ricerche Chimiche e Biochimiche G. Ronzoni, Milan, Italy.
Journal of Pharmaceutical and Biomedical Analysis
|April 25, 2018
Summary
This study provides the first in-depth chemical characterization of sulodexide, a heparinoid drug. Advanced analytical techniques reveal detailed structural features, crucial for quality control in pharmaceutical production.
Area of Science:
- Pharmacology
- Analytical Chemistry
- Biochemistry
Background:
- Sulodexide is a widely used pharmaceutical agent, a heparinoid with therapeutic applications in thromboembolic diseases and diabetic nephropathy.
- Despite its clinical use, comprehensive fine chemical characterization of sulodexide's components (heparin and dermatan sulfate) is lacking.
- Understanding the precise structure is vital for ensuring consistent drug efficacy and safety.
Purpose of the Study:
- To conduct an in-depth structural investigation of sulodexide, encompassing both the whole mixture and its isolated components.
- To analyze the molecular weight distribution and the mono-, di-, and oligosaccharide composition of sulodexide.
- To characterize fractions with varying affinities to antithrombin.
Main Methods:
- High-Performance Size Exclusion Chromatography with Triple Detector Array (HP-SEC/TDA)
- Two-Dimensional Nuclear Magnetic Resonance (2D-NMR) spectroscopy
- High-Performance Liquid Chromatography-Mass Spectrometry (HPLC-MS)
- Separation of fractions based on antithrombin affinity
Main Results:
- Detailed molecular weight distribution profiles were obtained for sulodexide.
- Comprehensive analysis of mono-, di-, and oligosaccharide composition was achieved.
- Structural features of fractions with graded antithrombin affinity were elucidated.
- The study provides a robust methodology for the structural profiling of sulodexide.
Conclusions:
- This work presents the first detailed fine chemical characterization of sulodexide.
- The applied analytical combination offers a powerful tool for assessing sulodexide's structural integrity.
- These findings are essential for pharmaceutical quality control and batch analysis of sulodexide.
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