Diosmin EP8

Test Items

Specification

CHARACTERS

-Appearance

Greyish-yellow or light yellow hygroscopic powder

-Solubility

Practically insoluble in water, soluble in dimethylsulphoxide, practically insoluble in alcohol. It dissolves in dilute solutions of alkali hydroxides.

IDENTIFICATION

A.Infrared absorption spectrophotometry(2.2.24)

Comparison: diosmin CRS

B.Examine the chromatograms obtained in the Assay

The principal peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution (a).

TESTS

-Iodine(2.2.36)&(2.5.10)

≤0.1%

-Related substances(HPLC)(2.2.29)

 --impurity A:acetoisovanillone

≤1.0%

 --impurity B:hesperidin

≤5.0%

 --impurity C:isorhoifin

≤3.0%

 --impurity E:linarin

≤3.0%

 --impurity F:diosmetin

≤3.0%

 --any other impurity

≤1.0%

 --total of other impurities and impurity A

≤1.0%

 --total

≤10.0%

-Heavy metals(2.4.8)

≤20ppm

-Water(2.5.12)

≤6.0%

-Sulphated ash(2.4.14)

≤0.2%

ASSAY(HPLC),anhydrous substance(2.2.29)

90.0%-102.0%

PARTTICLE SIZE

95% pass 80mesh

RESIDUAL SOLVENTS(2.4.24)&(5.4)

-Methanol

≤3000ppm

-Ethanol

≤5000ppm

-Pyridine

≤200ppm

MICROBIOLOGICAL TESTS(2.6.12)&(2.6.13)

-Total Plate Count

＜1000/g

-Enterobacteriaceae count

＜100/g

-Yeast and Molds

＜100/g

-Salmonella

Negative

-E.Coliform

Negative

-Staphaureus

Negative

-Ps.Aeroginosa

Negative

STORAGE CONDITIONS/TEMPERATURE: ROOM TEMPERATURE, PROTECT FROM LIGHT, AIR TIGHT.