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Steviol glycosides
Compositional guideline for 'Steviol glycosides' permitted for use in listed medicines
Name of the ingredient
Steviol glycoside (AAN)
Definition of the ingredient
The ingredient is obtained from the leaves of Stevia rebaudiana Bertoni. The leaves are extracted with hot water and the aqueous extract is passed through an adsorption resin to trap and concentrate the component steviol glycosides. The resin is washed with a solvent alcohol to release the glycosides and product is re-crystallized from methanol or aqueous ethanol. Ion exchange resins may be used in the purification process. The final product may be spray-dried.
Ingredient specific requirements
Except for the incidental constituents given below, requirements are the same as in the specification monograph of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) for Steviol glycosides prepared at the 69th JECFA (2008), published in FAO JECFA Monographs 5 (2008)*.
Test | Method reference | Acceptance criteria |
---|---|---|
Description |
Please refer to the FAO/WHO JECFA Monograph 5 (2008)* |
|
Characteristics | ||
Identification | ||
Assay | ||
Note: *Online Edition: "Combined Compendium of Food Additive Specifications" (pdf,111kb) |
Test | Method reference | Acceptance criteria |
---|---|---|
Incidental metals and non-metals | ||
Total heavy metals | BP (Appendix VII); Ph Eur method 2.4.8 | ≤ 20 ppm |
Pesticide residues and environmental contaminants: (including agricultural and veterinary substances) | BP (Appendix XI L); Ph Eur method 2.8.13 | Complies |
Key to abbreviations:
BP = British Pharmacopoeia
Ph Eur = European Pharmacopoeia