Name of the ingredient
Resveratrol
Definition of the ingredient
Resveratrol is manufactured by fermentation with genetically modified baker's yeast (S. cerevisiae), followed by extensive purification.
Molecular formula:
C14H1203
CAS Number:
501-36-0
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Off-white to slightly yellow powder | Visual | Must comply |
| Characteristics | ||
| Water content | Ph Eur 2.5.12 | NMT 2 % |
| Identification | ||
| IR | USP <197K> | IR spectrum must conform with reference standard |
| HPLC | USP <197K> | IR spectrum must conform with reference standard |
| Assay | ||
| HPLC | Retention time must conform | 98% - 101.0% (on an anhydrous and solvent-free basis) |
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Residual solvents | ||
| Ethanol | Ph Eur 2.4.24 | NMT 5000 ppm |
| Incidental metals and non-metals | ||
| Heavy metals (total) | Ph Eur 2.4.8 | NMT 10 ppm |
| Lead | Ph Eur 2.2.58 (ICP-MS) | NMT 1 ppm |
| Cadmium | Ph Eur 2.2.58 (ICP-MS) | NMT 1 ppm |
| Arsenic | Ph Eur 2.2.58 (ICP-MS) | NMT 1.5 ppm |
| Mercury | Ph Eur 2.2.58 (ICP-MS) | NMT 0.1 ppm |
| Other organic or inorganic impurities or toxins | ||
| Dihydroresveratrol | HPLC | NMT 0.5 % |
| Pinosylvin | HPLC | NMT 0.5 % |
| Coumaric acid | HPLC | NMT 0.5 % |
| Cinnamic acid | HPLC | NMT 0.5 % |
| Phloretic acid | HPLC | NMT 0.1 % |
| cis-Resveratrol | HPLC | NMT 0.1 % |
| Any single unknown impurity | HPLC | NMT 0.1 % |
| Total unknown impurities | HPLC | NMT 0.5 % |
| Microbiology | ||
| Total aerobic plate count (TAMC) | Ph Eur 2.6.12 | NMT 1000 CFU/g |
| Total yeast and mould (TYMC) | Ph Eur 2.6.12 | NMT 100 CFU/g |
| Notes | ||
| While substance manufacturers are encouraged to include limits for objectionable microorganisms, it is the product into which those substances are formulated that is subject to a legally binding set of criteria. The Therapeutic Goods Order No. 100 'Microbiological Standards for Medicines' mandates that any finished product that contains the ingredient, alone or in combination with other ingredients, must comply with the microbial acceptance criteria set by Clause 11 of the Order. | ||
Key to abbreviations
Ph Eur = European Pharmacopoeia
USP = United States Pharmacopoeia
CFU = Colony forming units
NMT = Not more than
HPLC = High-pressure liquid chromatography
IR = Infrared spectrophotometry
ICP-MS = Inductively coupled plasma mass spectrometry
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