Item
Specification
Result
Physical appearance
White or off-white crystalline powder
White crystalline powder
Identity by HPLC
The retention time is consistent with that of a reference standard
Conforms
Purity by HPLC(Area,%)
≥99.00%
99.76%
Largest single impurity
by HPLC (Area, %)
≤0.20%
0.10%
Total impurities by HPLC(Area,%)
≤1.00%
0.24%
Water Content(%)
≤0.50%
0.12%
Loss on drying
0.22%
Conclusion:
Qualified
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