Expiry Date: 

Fiveyears

Inspection Standard: 

EP7.0

Tests

Standards

Results

Appearance

White   or yellowish-white powder

White   powder

Solubility

Very slightly soluble in   water, 

slightly soluble in   alcohol.

Very slightly soluble in   water, 

slightly soluble in   alcohol.

Identification

A:   Melting point

199-203℃

199.5.0-200.6℃

B:   Specific absorbance

Max.287nm:   240-250

246%

C:   IR-spectrum

Complies   with reference spectrum

Complies   with reference spectrum

D:   Chemical reaction

Green   fluorescence at 365nm

Green   fluorescence at 365nm

Appearance   of solution

Not more intensely   colored 

than Reference Solution   BY7

Less   intensely colored than reference solution BY7

Related   substances

Method   A by HPLC:

Impurity   F

≤0.1%

0.02%

Any   single impurity

≤0.1%

＜0.1%

Total   impurities

≤0.2%

＜0.2%

Method   B by HPLC:

Any   single impurity

≤0.1%

＜0.1%

Total   impurities

≤0.2%

＜0.2%

Heavy   metals

≤20ppm

＜20ppm

Residual   methanol

≤3000ppm

Not   detected

Residual   DMSO

≤5000ppm

Not   detected

Residual   acetic acid

≤5000ppm

Not   detected

Impurity   K(aniline) by GC

≤5ppm

Not   detected

Loss on   drying

≤1.0%

0.21

Sulphated   ash

≤0.1%

0.08%

Assay 

98.5-101.0%

99.89%

Conclusion : Complies with EP7.0