Specification No. R 06
Resveratrol-Glycon HP*
*= high purity
Manufacturer: Interpharma Praha a.s., Czech Republic
Description: Min. 98 % trans-resveratrol-3-O-glucoside, extracted from the Polygonum cuspidatum root.
| 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% | NQ R 06 |
| Total impurities (HPLC, area %) | max. 2.0 % | NQ R 06 |
| trans-Resveratrol | max. 1.0 % | NQ R 06 |
| cis-Resveratrol | max. 0.2 % | NQ R 06 |
| cis-Resveratrol-3-O-glucoside | max. 0.2 % | NQ R 06 |
| Impurity A, unidentified (RRT 2.23) | max. 0.2 % | NQ R 06 |
| Impurity B, unidentified (RRT 2.28) | max. 0.3 % | NQ R 06 |
| Impurity C, unidentified (RRT 2.33) | max. 1.0 % | NQ R 06 |
| Any other unidentified impurity | max. 0.1 % | NQ R 06 |
| trans-Resveratrol-3-O-glucoside (HPLC assay, external calibration, calculated on dry matter) | 96-104 % (w/w) ** |
NQ R 06 |
| ** Note: The actual value may exceed 100 % due to the inherent standard deviation of the method | ||
| Emodin (HPLC assay, external calibration, calculated on dry matter) | below LOQ*** | NQ R 06 |
| Emodin glucoside (HPLC assay, external calibration as emodin, calculated on dry matter) | below LOQ*** | NQ R 06 |
| *** LOQ = limits of quantification, 0.1 mg emodin/g sample (0.01 %) | ||
| Loss on drying (105 °C): | max. 4.0 % | Ph.Eur 5th Ed. <2.2.32> |
| 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 |
| Ethanol (GC): | max. 2500 ppm**** | Ph.Eur 5th Ed.<2.2.28>, NQ R06 |
| **** No solvents other than ethanol and water were used in the manufacturing process and none are present above their LOQ | ||
| Microbiological tests: | ||
| Total aerobic microbial count: | max. 10 000 cfu/g | Ph.Eur 5th Ed. 2005, <2.6.12> |
| Combined yeast and molds count: | max. 100 cfu/g | Ph.Eur 5th Ed. 2005, <2.6.12> |
| Escherichia coli in 1 g: | absent | Ph.Eur 5th Ed. 2005, <2.6.13> |
| Salmonella in 10 g: | absent | Ph.Eur 5th Ed. 2005, <2.6.13> |
| Staphylococcus aureus in 1 g: | absent | Ph.Eur 5th Ed. 2005, <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 | ||
- INTERPHARMA PRAHA, a.s., Komoranska 955, 143 10 Praha 12, Czech Republic
- Business Development: 00420-241 773 242
- Secretariat: 00420-241 773 242, Fax: 00420-241 773 235
- Email: