Specification No. I 32
Bio-Quercetin (50 % isoquercitrin, bioavailable form of quercetin)
BULK
Description: Purified powdered extract from the seeds and pods of the brazilian shrub “fava d´anta” (Dimorphandra mollis), with highly concentrated isoquercitrin, the most bioavailable form of quercetin. The extract is analytically standardized to minimum 50 % (w/w) isoquercitrin (quercetin-3-glucoside) and contains also 25 - 45 % (w/w) rutin (quercetin-3-rhamnoglucoside).
| Macroscopic characters: | |
| Color: | yellow, yellow brownish or yellow greenish |
| Taste: | slightly bitter-sweet |
| Solubility: | partially soluble in water, soluble in alcohols |
| Tests: | Limits: | Methods: |
| Appearance: | yellow powder | |
| Loss on drying (120 °C): | max. 7.0 % | 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 I 32, Ph.Eur 5th Ed. 2005, <2.2.28> |
| Isoquercitrin (HPLC, external standard as isoquercitrin, calcul. on a dry matter) | min. 500 mg/g | NQ I 32, test No. 3 Ph.Eur 5th Ed. 2005, <2.2.29> |
| Rutin HPLC, external standard as rutin, calculated on a dry matter):: |
250 - 450 mg/g | NQ I 32, test No. 6 Ph.Eur 5th Ed. 2005, <2.2.29> |
| Microbiological test: | ||
| 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 5thh Ed. 2005, <2.6.13> |
| Storage conditions: Keep in dark, up to 25°C | ||
| Shelf life: 2 years | ||
*NQ = Norm of Quality
This specification supersedes the specification No. I 32, version 2, issued on September 5, 2005.