Sophora Japonica L. extract Rutin Troxerutin

Items

Specification

Result

Characteristics

-Appearance

-Solubility

Yellowish-green crystalline powder,

hydroscopic.

Freely soluble in water, slightly

soluble in ethanol; practically

insoluble in methylene chloride

Conforms

Conforms

Identification

Identical with that of the reference

(comparison:troxerutin CRS)

Obtained in the test for composition

Conforms

Conforms

Tests

-principal peak

Trihydroxyethylrutin

≥80%

87.00%

-any other peak

Monohydroxyethylrutin

Dihydroxyethylrutin

Tetrahydroxyethylrutin

For each peak,maximum 5%, except for 1 peak which can be  maximum 10%

0.42%

8.00%

3.00%

-Loss on drying         

≤5.0%

2.20%

-Sulphated ashes

≤0.4%

0.08%

Heavy metals

≤20ppm

<20ppm

Ethylene oxide (GC)

≤1ppm

<1ppm

Assay(UV, Accoding to dried substance)

95.0%-105.0%

99.80%

Microbiological test

-Total plate count

-Yeast & mould

-E.Coli

≤1000cfu/g

≤100cfu/g

Absent

<1000cfu/g

<100cfu/g

Absent