ITEM

 STANDARD

RESULT

Identification：Positive

Positive reaction

Positive reaction

Loss on drying

0.5% MAX

         0.26%

Residue on ignition

0.5% MAX

0.17%

Heavy metal

          10 ppm MAX

        Conform

Individual  impurity

           0.1% MAX

        Conform

Total impurities

           1.0% MAX

        Conform

          Assay（TCL）

≥99.0%

        ≥99.0%

         Assay（HPLC）

≥99.0%

         99.57%

Melting point

117～120℃

     118.3～118.5℃

CONCLUSION : COMPLY WITH THE REQUIREMENT BP2018/USP39