1D and 2D-HSQC NMR: Two Methods to Distinguish and Characterize Heparin From Different Animal and Tissue Sources

Area of Science:

• Analytical Chemistry
• Biochemistry
• Pharmacology

Background:

• The US FDA supports using bovine heparin to prevent shortages and contamination risks associated with porcine heparin.
• Heparin's critical role in medicine necessitates reliable methods for origin verification and quality control.

Purpose of the Study:

• To compare heparin sodium from different animal sources using Nuclear Magnetic Resonance (NMR) spectroscopy.
• To establish NMR-based methods for identifying heparin origin and assessing its quality.

Main Methods:

• A 1D-NMR method was employed to analyze heparin sodium from bovine intestinal, bovine lung, porcine intestinal, and ovine intestinal origins.
• A quantitative 2D-HSQC NMR method was utilized for detailed compositional analysis and quality assessment.

Main Results:

• 1D-NMR signal intensity ratios effectively identified the origin of heparin sodium and confirmed sample labeling.
• 2D-HSQC NMR provided detailed insights into mono- and disaccharide composition, enabling origin distinction and quality evaluation.
• The combination of 1D and 2D NMR data ensures the identity and purity of heparin drug products.

Conclusions:

• 1D-NMR is a rapid tool for verifying heparin origin and ensuring correct labeling.
• 2D-HSQC NMR offers comprehensive analysis for assessing heparin quality and the industrial production process.
• NMR spectroscopy is crucial for assuring the identity, purity, and quality of heparin sodium for pharmaceutical use.