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-brown or yellow-green
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>
Ethylacetate (GC): max. 2500 ppm NQ I 32
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: <10 000 cfu/g Ph.Eur 5th Ed. 2005, <2.6.12>
Combined yeast and molds count: <100 cfu/g Ph.Eur 5th Ed. 2005, <2.6.12>
Escherichia coli in 1 g absent Ph.Eur 5th Ed. 2005, <2.6.12>
Salmonella in 10 g: absent Ph.Eur 5th Ed. 2005, <2.6.12>
Staphylococcus aureus in 1 g: absent Ph.Eur 5thh Ed. 2005, <2.6.12>
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.

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:
 

[TOP]