Specificatin

  EP 7.8

ITEM

CRITERIA

 RESULTES

  Appearance

   A white or almost white powder.

    White powder

  Identification-IR

  Conform to the reference spectrum

    Conforms

  Identification- UV

 Maximal absorptions at 254nm,   minimum absorption at 242nm

    Conforms

  Water

   ≤ 0.3%

     0.19%

  Residual solvents

  Methanol

   Less than 3000ppm

     N. D.

  Ethanol

   Less than 5000ppm

     N. D.

  Ethyl ether

   Less than 5000ppm

    62ppm

  Acetone

   Less than 5000ppm

    505ppm

  Ethyl acetate

   Less than 5000ppm

    N. D.

  Dichloromethane

   Less than 600ppm

    N. D.

  Dimethylformamide

   Less than 880ppm

    N. D.

  Related substances

  Impurity A

   ≤ 0.15%

    0.04%

  Impurity B

   ≤ 0.3%

    0.03%

  Impurity F

   ≤ 0.2%

    0.02%

  Impurity G

    ≤ 0.2%

    0.04%

  Impurity H

    ≤ 0.15%

    N. D.

  Other individual impurity

    ≤ 0.10%

    0.04%

  Total impurities

    ≤ 0.6%

    0.23%

  Sulfated ash

    ≤ 0.1%

    0.07%

  Heavy metals

    ≤ 10ppm

    <10ppm

Assay (Dried substance)

    99.0~101.0%

    99.9%

  Conclusion

    Conforms to EP