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Compositional guideline: Resveratrol

12 July 2019

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

Table 1. Ingredient specific requirements
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)
Table 2. Incidental constituents
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