DIOSMIN HESPERIDIN 90:10 POWDER

Name

Diosmin

CAS

520-27-4

EINECS

208-289-7

Molecular Formula

C28H32O15

Molecular Weight

609

QualityStandard

EP8.0

Package Size

25kg/drum

Brief Introduction

Greyish-yellow or light yellow hygroscopic powder. Practically insoluble in water, soluble in dimethyl sulphoxide, practically insoluble in alcohol. It dissolves in dilute solutions of alkali hydroxides.

Nature of Test

Specifications

Test Results

CHARACTERS

- Appearance

Greyish-yellow or light yellow hygroscopic powder.

Light yellow hygroscopic powder.

- Solubility

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

Conforms

IDENTIFICATION

A. Infrared absorption spectrophotometry(2.2.24)

Comparison: diosmin CRS

Conforms

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).

Conforms

TESTS

- Iodine(2.2.36) & (2.5.10)

≤0.1%

< 0.1 %

- Related substances (HPLC)(2.2.29)

-- impurity A: acetoisovanillone

≤1.0 %

0.07 %

-- impurity B: hesperidin

≤5.0 %

1.1 %

-- impurity C: isorhoifin

≤3.0 %

0.79 %

-- impurity E: linarin

≤3.0 %

0.84 %

-- impurity F: diosmetin

≤3.0 %

0.81 %

--any other impurity

≤1.0 %

<1.0%

--total of other impurities and impurity A

≤1.0 %

0.65 %

--total

≤10.0 %

4.5 %

- Heavy metals(2.4.8)

≤20 ppm

< 20 ppm

- Water(2.5.12)

≤6.0 %

3.5 %

- Sulphated ash(2.4.14)

≤0.2 %

0.12 %

ASSAY(HPLC),anhydrous substance(2.2.29)

90.0%-102.0%

95.3 %

PARTTICLE SIZE DISTRIBUTION

- Particle size (by Laser Granulometry)

100%≤10 microns

100% < 10 microns

RESIDUAL SOLVENTS(2.4.24) & (5.4)

- Methanol

≤3000 ppm

23 ppm

- Ethanol

≤5000 ppm

0 ppm

- Pyridine

≤200 ppm

80 ppm

MICROBIOLOGICAL TESTS(2.6.12) & (2.6.13)

- Total Plate Count

< 103 / g

< 102 / g

- Yeasts and Molds

< 102 / g

< 10 / g

- Salmonella

Negative in 1 g

Negative in 1 g

- E. Coliform

Negative in 1 g

Negative in 1 g

CONCLUSION: THE TEST RESULTS CONFORM TO Ph.Eur. 8.0.

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