Quality Assurance Considerations

Since usage in foods is anticipated for Cyclodextrin’s and CMCyclodextrin’s, the most rigorous quality assurance standards must be met. Not only is the purity of the CMCyclodextrin important, but the complex must be well characterized. Analyses of the Cyclodextrin’s and complexes by the following techniques have been reported in the technical literature:

• NMR
• Differential Scanning Calorimetry
• Thermal Stability Analysis
• Aqueous Size Exclusion Chromatography
• High Pressure Liquid Chromatography
• Thin Layer Chromatography
• Fourier Transform Spectroscopy
• Chemical and Enzymatic Hydrolysis
• Mass Spectrometry (fast atom bombardment and other soft ionization techniques)
• Polarimetry

The following checklists can be adapted to create your own product specifications:

Chemically Modified Cyclodextrins

Identification

• Appearance
• Aqueous Solubility
• Peak Asymmetry Analysis
• Specific Rotation
• Mesh Size
• Molecular Weight Distribution
• Substituent Distribution
• Degree of Substitution
• Extent of Linear Polymerization

Purity

• CMCyclodextrin content (all isomers)
• Residual native Cyclodextrin’s (unsubstituted)
• Residual reagents or chemical byproducts
• Products from synthesis or purification
• Residue on Ignition
• Heavy Metals
• Arsenic

Safety

• Safety Test (USP XXII)
• Pyrogenicity
• Microbial limit tests