Specification No. R 02
plant extract composition - bulk
Description: Mixture of concentrated and standardized plant extracts derived from: Dimorphandra mollis, Curcuma longa and Piper nigrum. Contains also Regrapex-R® forte, a concentrated extract of Vitis vinifera (whole red grape) with min. 35% trans-resveratrol, and diindolylmethane (DIM), a natural indole derived from plants of the Broccoli genus.
| Macroscopic characters: | |
| Color: | orange-brown |
| Odor: | slightly pungent |
| Taste: | spicy-bitter |
| Solubility: | clear solution in 95% acetonitrile (acetone)/5% water, poorly soluble in water |
| Composition: | |
| 1 g of the bulk consists of the following: | |
| Curcuma longa (Curcumin, specification No. C 03) (HPLC, min. 90% curcuminoids, w/w): |
335 - 355 mg |
| Vitis vinifera Whole red grape extract with 35% resveratrol) (Regrapex-R® forte, specification No. V 07) (HPLC, min. 35% trans- resveratrol w/w, min. 50% polyphenols by Folin, calculated as GAE): |
300 - 330 mg |
| Dimorphandra mollis (Bio-Quercetin®, specification No. I 32) (HPLC, min. 50% isoquercitrin (quercetin-3-glucoside, w/w) and 25-45% rutin (quercetin-3-rutinoside, w/w): |
220 - 250 mg |
| DIM (Diindolylmethane, specification No. D 09) (HPLC min. 98% diindolylmethane, w/w): |
60 - 62 mg |
| Piper nigrum (Piperine, specification No. P 08) (HPLC, min. 90% piperine, w/w): |
2.8 - 3 mg |
| Content of active ingredients in 1 g of the composition: | |
| Curcuminoids (curcumin, demethoxy- and bisdemethoxycurcumin) | min. 320 mg |
| Grape polyphenols (by Folin as GAE) | min. 160 mg |
| Trans-Resveratrol | min. 110 mg |
| Isoquercitrin (quercetin-3-glucoside) | min. 125 mg |
| Rutin (quercetin-3-rutinoside) | min. 60 mg |
| Diindolylmethane | min. 60 mg |
| Piperine | min. 2.7 mg |
| Tests: | Limits: | Methods: |
| Appearance: | orange-brown powder | |
| Loss on drying (105 °C): | max. 5.0% | Ph. Eur. 5th Ed., <2.2.32> |
| Heavy metals: | max. 0.002 % | Ph. Eur. 5th Ed., <2.4.8> |
| Ethanol (GC): | max. 5000 ppm | NQ R02, Ph.Eur5th Ed., <2.2.28> |
| Acetone (GC): | max. 2000 ppm | NQ R02, Ph.Eur5th Ed., <2.2.28> |
| Ethyl acetate (GC): | max. 200 ppm | NQ R02, Ph.Eur5th Ed., <2.2.28> |
| Microbiological test: | ||
| Total aerobic microbial count: | <10 000 cfu/g | Ph. Eur. 5th Ed., <2.6.12> |
| Combined yeast and molds count: | <100 cfu/g | Ph. Eur. 5th Ed., <2.6.12> |
| Escherichia coli in 1 g | absent | Ph. Eur. 5th Ed., <2.6.13> |
| Salmonella in 10 g: | absent | Ph. Eur. 5th Ed., <2.6.13> |
| Staphylococcus aureus in 1 g: | absent | Ph. Eur. 5th Ed., <2.6.13> |
| Storage conditions: Keep in well closed double PE bags. Keep in dry, dark place up to 25ºC | ||
| Shelf life: 1 years | ||
This specification supersedes the specification No. R02, version 1. issued on August 28, 2003
*NQ = Norm of Quality