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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 |