Specification No. R 05
Resveratrol HP*
*= high purity
Manufacturer: Interpharma Praha a.s., Czech Republic
Description: Min. 98% trans-resveratrol, extracted from the Polygonum cuspidatum root.
| Substance identification: | |
| CAS No.: | 501-36-0 |
| Molecular weight: | 228.25 |
| Chemical formula: | C14H12O3 |
| Chemical name: | 5-[(1E)-2-(4-Hydroxyphenyl) ethenyl]-1, 3-benzenediol Trans-3, 4´,5-trihydroxystilbene |
| Physical data: | |
| Appearance: | off white to slightly yellow-brownish powder |
| Solubility: | fairly soluble in alcohols, almost insoluble in water |
| Tests: | Limits: | Methods: |
| trans-Resveratrol (HPLC purity) | min. 98% | NQ R 05 |
| Total impurities (HPLC, area %) | max. 2.0 % | NQ R 05 |
| cis-Resveratrol | max. 0.2 % | NQ R 05 |
| trans-Resveratrol-3-O-glucoside | max. 1.0 % | NQ R 05 |
| cis-Resveratrol-3-O-glucoside | max. 0.2 % | NQ R 05 |
| Impurity A, unidentified (RRT 1.08) | max. 0.4 % | NQ R 05 |
| Impurity B, unidentified (RRT 1.11) | max. 0.2 % | NQ R 05 |
| Impurity C, unidentified (RRT 1.27) | max. 0.2 % | NQ R 05 |
| Impurity D, unidentified (RRT 1.36) | max. 0.3 % | NQ R 05 |
| Impurity E, unidentified (RRT 1.37) | max. 0.5 % | NQ R 05 |
| Impurity F, unidentified (RRT 1.38) | max. 0.3 % | NQ R 05 |
| Impurity G, unidentified (RRT 1.47) | max. 1.0 % | NQ R 05 |
| Impurity H, unidentified (RRT 1.49) | max. 0.2 % | NQ R 05 |
| Any other unidentified impurity | max. 0.1 % | NQ R 05 |
| trans-Resveratrol (HPLC assay, external calibration, calculated on dry matter) | 96-104 % (w/w) ** | NQ R 05 |
| ** 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 05 |
| Emodin glucoside (HPLC assay, external calibration as emodin, calcul. on dry matter) | below LOQ*** | NQ R 05 |
| *** LOQ = limits of quantification, 0.1 mg emodin/g sample (0.01 %) | ||
| Ethanol (GC): | max. 5000 ppm**** | Ph.Eur 5th Ed.<2.2.28>, NQ R05 |
| **** 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 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 |
| 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 guidelines. | ||
| 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
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