檢測項(xiàng)
Item
檢測內(nèi)容
Specification
檢測結(jié)果
Result
外觀
Physical appearance
白色或類白色結(jié)晶性粉末
White or off white crystalline powder
白色結(jié)晶性粉末
White crystalline powder
識別
Identify
核磁確認(rèn)與供試樣品保持一致
NHR confirmation is consistent with the test sample
與樣品一致
Conformed
液相出峰保留時間與供試樣品保持一致
The peak time of HPLC is consistent with the test sample
有關(guān)物質(zhì)
Related substances
高效液相色譜純度≥99.00%/Purity of HPLC≥99.00%
99.97%
單雜≤0.50%/Max Single Impurity≤0.50%
0.03%
總雜質(zhì)≤1.00%/Total impurity≤1.00%
含量/Titration content
98.00%~102.00%
99.92%
水份/Water
≤0.50%
0.06%
重金屬/Heavy Metals
≤20ppm
未檢出/N.D
熔點(diǎn)/Melting points
120.0℃~126.0℃
122.3℃~123.7℃
結(jié)論
Detection result
合格
Qualified
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