检测项
Item
检测内容
Specification
检测结果
Result
外观
Physical appearance
白色或类白色结晶性粉末
White or off white crystalline powder
白色结晶性粉末
White crystalline powder
识别
Identify
核磁确认与供试样品保持一致
NHR confirmation is consistent with the test sample
与样品一致
Conformed
液相出峰保留时间与供试样品保持一致
The peak time of HPLC is consistent with the test sample
有关物质
Related substances
高效液相色谱纯度≥99.00%/Purity of HPLC≥99.00%
99.97%
单杂≤0.50%/Max Single Impurity≤0.50%
0.03%
总杂质≤1.00%/Total impurity≤1.00%
含量/Titration content
98.00%~102.00%
99.92%
水份/Water
≤0.50%
0.06%
重金属/Heavy Metals
≤20ppm
未检出/N.D
熔点/Melting points
120.0℃~126.0℃
122.3℃~123.7℃
结论
Detection result
合格
Qualified
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