项目
Items 标准规定
Limits 检验结果
Rults
1.外观
Dcription 类白色结晶性粉末
White to cream,crystalline powder 合规定
Meets The Requirements
2.鉴别
Identification IR 合规定
Meets The Requirements
3.熔点
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.灼烧残渣
Ridue On Ignition≤0.1%0.04%
7.属
Heavy Metals≤20μg/g 合规定
Meets The Requirements
8.相关物质
Chromatographic Purity 单一杂质Single:≤1.0%0.23%
总杂质Sum:≤2.5%0.81%
9.挥发物
Organic Volatile Impuriti 应合规定
Meets The Requirements 合规定
Meets The Requirements
10.残余溶剂
Ridual Solvents 应合规定
Meets The Requirements 合规定
Meets The Requirements
11.含量测定
Assay 97.0-102.0%99.63%
12.细度
Particle size Micronized 合规定
Meets The Requirements
代表量:
Quantity:100kg
结论:本品按照美国药典32版检验,结果合规定.
Conclusion:Conform with USP32.
贮藏:避光,密闭保存.
Packaging and storage:Prerve in tight,light-ristant containers.