Analysis Items | Specifications | Methods |
Identifications |
- IR
| IR spectrum is concordant with the reference spectrum of Rutin RS-<197K> |
- UV
| Absorptivity at the maximum at 358 nm is 30.5–33.0. <197U> |
- HPLC
| Retention time of the sample matches with the standard in HPLC purity test. |
- Solubility
| Insoluble in water, slight soluble in Ethanol. |
Active Ingredients Tests |
Rutin (UV) | 95.00%-101.00% | USP43<857> |
Total impurities | ≤4.00% | USP43<621> |
Kaempferol 3-rutinoside | ≤2.00% | USP43<621> |
Isoquercitroside | ≤2.00% | USP43<621> |
Quercetin | ≤2.00% | USP43<621> |
Unspecified impurity | ≤1.00 % | USP43<621> |
Physical Tests |
Appearance | Yellow Green Fine Powder | Visual |
Particle size | NLT 95% pass 80mesh | USP43<786> |
Water | 7.50%-9.50% | USP43<921> |
Residue on Ignition | ≤0.10% | USP43<281> |
Chemical Tests |
Heavy Metals | ≤10.00ppm | USP43<231> |
Pb | ≤3.00ppm | USP43<211> |
As | ≤1.00ppm | USP43<251> |
Cd | ≤1.00ppm | USP43<232> |
Hg | ≤0.10ppm | USP43<261> |
Methanol Insoluble substance | ≤3.00% | USP43<561> |
Microbiological Tests |
Total Bacterial Counts | ≤1,000cfu/g | USP43<2021> |
Yeasts and Molds | ≤100cfu/g | USP43<2021> |
E. Coli | Negative in 1g | USP43<2022> |
Salmonella | Negative in 10g | USP43<2022> |
* Statements : Allergen Free,Irradiated free, GMO free, Additives free. |