Items

Specification

Results

Appearance

   White or yellowish-white powder

Complies

      Solubility

Very slightly soluble in water, 

slightly soluble in alcohol.

Complies

Identification

A: Melting point

199-203°C

199.5-201.1°C

B: Specific absorbance

Max.287nm: 240-250

242

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%

0.04%

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%

0.13%

Sulphated ash

≤0.1%

0.08%

Assay 

98.5-101.0%

99.80%

Conclusion

This product complies with BP2012