项目

规格

结果

外观Appearance

白色或微黄色结晶粉末

White or yellowish crystalline powder

一致 consistent

溶液外观

Appearance of solution

不深于标准液Y₆ Not more intensely colored than the reference solution Y₆

符合规定

Conforms

熔点

Melting point

235-240 ℃

235.1-239.7℃

溶解度Solubility

水分Water

甲醇Methanol

氯代甲烷Methylene chloride

微溶Sparingly soluble

可溶Soluble

完全不溶Practically insoluble

符合规定Conforms

符合规定Conforms

符合规定Conforms

鉴别Identification

• 紫外吸收UV absorption
• 红外光谱IR spectrum
• 薄层

Thin layer chromotography

• 氯化物检测Chlorides test

3.2-3.4ratio

符合规定Conforms

符合规定Conforms

符合规定Conforms

符合规定Conforms

测试Tests

• 相关物质Related substance

i)单一杂质 single impurity

ii) 总杂质total impurity

• 重金属Heavy metals
• 干燥失重Loss on drying
• 灰分Sulphated ash
• 酸碱度PH(1% aqueous solution)

0.1%

0.3%

20ppm

≤0.5%

≤0.1%

4.5-6.0

0.03%

0.1%

<20ppm

0.06%

0.05%

4.91

含量Assay   

99.0%-101.0%

99.68%