Specification No. V 07
Regrapex-R® forte
whole grape extract enriched with 35 % resveratrol
Manufacturer: Interpharma Praha a.s., Czech Republic
Description: A whole extract from red grapes of Vitis vinifera, grown in southern France under the European Community rules for environmentally controlled agriculture. The product contains concentrated active principles found in red grapes (polyphenolic acids, flavonoids, anthocyanins and oligomeric proanthocyanidines - OPC´s) and is standardized to min. 35 % (w/w by HPLC) of resveratrol complex (trans-resveratrol and its glucoside).
| Macroscopic characters: | |
| Color: | violett brown to violett grey powder |
| Odor: | odorless |
| Taste: | characteristic bitter-astringent |
| Solubility: | slightly soluble in water, soluble in alcohols and ethylacetate |
| Composition: | |
| 1 g of the bulk consists of: | |
Whole red grape extract from Vitis vinifera |
270 - 500 mg |
Resveratrol extract from Polygonum cuspidatum |
500 - 730 mg |
| Tests: | Limits: | Methods: |
| Appearance: | violett brown to violett grey powder | |
| Resveratrol complex (trans-resveratrol and its glucoside, piceid) (HPLC, external standard as trans-resveratrol and piceid, calculated on dry matter): | min. 350 mg/g | Ph. Eur. 6th Ed. 2008 <2.2.29> NQ V07 |
| Emodin complex (emodin and emodin glucoside) (HPLC, external standard as emodin, calculated on dry matter): | max. 45 mg/g | Ph. Eur. 6th Ed. 2008 <2.2.29> NQ V07 |
| Total polyphenols (by Folin-Ciocalteu method, calculated as gallic acid equivalent, GAE) | min. 500 mg/g | NQ V07 |
| Loss on drying (105 °C): | max. 10.0 % | Ph. Eur. 6th Ed. 2008 <2.2.32> |
| Ethanol (GC): | max. 5000 ppm | Ph. Eur. 6th Ed. 2008 <2.2.32>, NQ V07 |
| Heavy metals: | ||
| Hg | max. 1 ppm | by AMA (externally) |
| Cd | max. 1 ppm | by ICP-MS (externally) |
| As | max. 2 ppm | by ICP-MS (externally) |
| Pb | max. 3 ppm | by ICP-MS (externally) |
| Microbiological test: | ||
| Total aerobic microbial count: | <10 000 cfu/g | Ph.Eur 6th Ed. 2008 <2.6.12> |
| Combined yeast and molds count: | <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> |
| Storage conditions: Keep in dark, up to 25°C | ||
| Shelf life: 3 years (to be understood as a retest date) | ||
*NQ = Norm of Quality
This specification supersedes the specification No. V07, version 3., issued on September 08, 2006
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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