SPECIFICATION

Characters

Appearance

Light yellow hygro-scopic powder

Solubility

Practically insoluble in water,  soluble in dimethyl sulphoxide, practically insoluble in alcohol, It dissolves in dilute solutions of alkali hydroxides

Identification

A.UV

UV spectrum of test solution in a range from 240 to 500 nm must have maximums at:

(252±2) nm

(268±2) nm

(344±2) nm

And minimums at:

(263±2) nm

About 292 nm

B.HPLC

Retention times of the principal peaks on the chromatogram of test solution must correspond to retention times of the principal peaks of diosmin and hesperidin on the chromatogram of standard solution

TESTS

Iodine

≤0.1%

Related substances(HPLC)

Isorhoifolin

0.9%-2.8%

Linarin

0.9%-2.8%

Diosmetin

≤1.0%

Any unspecified impurity

≤3.0%

Sum of all impurities(without diosmin)

≤13.0%

Heavy metals

≤10ppm

Iron

≤100ppm

Loss on drying

≤6.0%

Sulphated ash

≤0.2%

ASSAY(HPLC),anhydrous substance

Sum of flavonoids

97.0%-103.0%

Diosmin

87.0%-93.0%

Hesperidin

2.5%-5.0%

RESIDUAL SOLVENTS

Methanol

≤3000ppm

Ethanol

≤0.5%

Pyridine

≤200ppm

MICROBIOLGICAL TESTS

Total Plate Count/1g

<1000

Yeasts and Molds/1g

<100

E.Coliform/1g

Absence

SPECIAL REQUIRMENT

Particle size

D90≤3um

D50≤1um

D10≤0.3um

D[4,3]≤1.6UM