Specification No. R 06
Resveratrol-Glycon HP*
*= high purity
Manufacturer: Interpharma Praha a.s., Czech Republic
Description: Min. 98 % trans-resveratrol-3-O-glucoside (resveratrol glycon).
| Substance identification: | |
| CAS No.: | 65914-17-2 |
| Molecular weight: | 390.39 |
| Chemical formula: | C20H22O8 |
| Chemical name: | 4´, 5-Dihydroxy-3-β-D-glucopyranosyloxy-trans-stilbene trans -Resveratrol-3-O-β -D-glucopyranoside |
| Other names: | Resveratrol glucoside |
| Physical data: | |
| Appearance: | off-white to yellow powder |
| Solubility: | soluble in alcohols, slightly soluble in water |
| Tests: | Limits: | Methods: |
| trans-Resveratrol-3-O-glucoside (HPLC purity) | min.98 %(area) | Ph. Eur. 6th Ed. <2.2.29>, NQ R06 test No.1 |
| Total impurities (HPLC, area %) | max. 2.0 % | Ph. Eur. 6th Ed. <2.2.29>, NQ R06 test No.2 |
| trans-Resveratrol | max. 1.0 % | Ph. Eur. 6th Ed. <2.2.29>, NQ R06 test No.3 |
| cis-Resveratrol | max. 0.2 % | Ph. Eur. 6th Ed. <2.2.29>, NQ R06 test No.4 |
| cis-Resveratrol-3-O-glucoside | max. 0.2 % | Ph. Eur. 6th Ed. <2.2.29>, NQ R06 test No.5 |
| Impurity A, unidentified (RRT 2.23) | max. 0.2 % | Ph. Eur. 6th Ed. <2.2.29>, NQ R06 test No.6 |
| Impurity B, unidentified (RRT 2.28) | max. 0.3 % | Ph. Eur. 6th Ed. <2.2.29>, NQ R06 test No.7 |
| Impurity C, unidentified (RRT 2.33) | max. 1.0 % | Ph. Eur. 6th Ed. <2.2.29>, NQ R06 test No.8 |
| Any other unidentified impurity | max. 0.1 % | Ph. Eur. 6th Ed. <2.2.29>, NQ R06 test No.9 |
| trans-Resveratrol-3-O-glucoside (HPLC assay, external calibration, calculated on dry matter) | 96-104 % (w/w) ** |
Ph. Eur. 6th Ed. <2.2.29>, NQ R06 test No.10 |
| Emodin (LC-MS, external standard) | max. 0.01% | NQ R06 test No.11 |
| Emodin glucoside (LC-MS, external std) | max. 0.01% | NQ R06 test No.12 |
| Note: LC-MS analyses are provided externally. | ||
| Ethanol (GC): | max. 2500 ppm | Ph. Eur. 6th Ed. <2.2.29>, NQ R06 test No.13 |
| No solvents other than ethanol and water were used in the manufacturing process and none are present above their LOQ | ||
| Loss on drying (105 °C): | max. 4.0 % | Ph.Eur 6th Ed. <2.2.32>, NQ R06 test No.14 |
| Heavy metals: | max. 0.002 % | Ph.Eur 5th Ed. <2.4.8> |
| As | max. 2 ppm | by ICP-MS |
| Pb | max. 2 ppm | by ICP-MS |
| Cd | max. 1 ppm | by ICP-MS |
| Hg | max. 1 ppm | by ICP-MS |
| Microbiological tests: | ||
| Total aerobic microbial count: | max. 10 000 cfu/g | Ph.Eur 6th Ed. 2008, <2.6.12> |
| Combined yeast and molds count: | max. 100 cfu/g | Ph.Eur 6th Ed. 2008, <2.6.12> |
| Escherichia coli in 1 g: | absent | Ph.Eur 6th Ed. 2008, <2.6.13> |
| Salmonella in 10 g: | absent | Ph.Eur 6th Ed. 2008, <2.6.13> |
| Staphylococcus aureus in 1 g: | absent | Ph.Eur 6th Ed. 2008, <2.6.13> |
| The specification is established according to the ICH Q3A / Q6A guidance | ||
| Storage conditions: Keep in dark, up to 25°C | ||
| Shelf life: 3 years | ||