項目
Items 標準規定
Limits 檢驗結果
Rults
1.外觀
Dcription 類白色結晶性粉末
White to cream,crystalline powder 合規定
Meets The Requirements
2.鑒別
Identification IR 合規定
Meets The Requirements
3.熔點
Melt Point About 196℃197.8℃
4.旋光度
Specific Rotation+98 o-+104 o+101.0 o
5.干燥失重
Loss On Drying≤2.0%0.10%
6.灼燒殘渣
Ridue On Ignition≤0.1%0.04%
7.屬
Heavy Metals≤20μg/g 合規定
Meets The Requirements
8.相關物質
Chromatographic Purity 單一雜質Single:≤1.0%0.23%
總雜質Sum:≤2.5%0.81%
9.揮發物
Organic Volatile Impuriti 應合規定
Meets The Requirements 合規定
Meets The Requirements
10.殘余溶劑
Ridual Solvents 應合規定
Meets The Requirements 合規定
Meets The Requirements
11.含量測定
Assay 97.0-102.0%99.63%
12.細度
Particle size Micronized 合規定
Meets The Requirements
代表量:
Quantity:100kg
結論:本品按照美國藥典32版檢驗,結果合規定.
Conclusion:Conform with USP32.
貯藏:避光,密閉保存.
Packaging and storage:Prerve in tight,light-ristant containers.



