Test  Item

Analysis  Specification

Result

Appearance

White to off white power

Complies

Identification

HPLC

Complies

Loss on drying

≤1.0%

0.27%

Related substances

(by HPLC)

Pentafluorophenol  ≤ 0.50%

Phosphoramidate methyl ester≤ 0.15%

Phosphoramidate ethyl impurity ≤ 0.15%

Any other individual impurity ≤ 0.30%

Total impurities ≤ 1.0%

0.10%

Undetected

Undetected

Undetected

0.10%

Enantiomer(by HPLC)

≤ 0.50%

0.06%

Assay by HPLC

(on dried basis)

98.0%~102.0%

99.40%

Conclusion

The product Conform  to Enterprise Standard