項目

規(guī)格

結(jié)果

外觀Appearance

白色或微黃色結(jié)晶粉末

White or yellowish crystalline powder

一致 consistent

溶液外觀

Appearance of solution

不深于標(biāo)準(zhǔn)液Y₆ Not more intensely colored than the reference solution Y₆

符合規(guī)定

Conforms

熔點

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

符合規(guī)定Conforms

符合規(guī)定Conforms

符合規(guī)定Conforms

鑒別Identification

• 紫外吸收UV absorption
• 紅外光譜IR spectrum
• 薄層

Thin layer chromotography

• 氯化物檢測Chlorides test

3.2-3.4ratio

符合規(guī)定Conforms

符合規(guī)定Conforms

符合規(guī)定Conforms

符合規(guī)定Conforms

測試Tests

• 相關(guān)物質(zhì)Related substance

i)單一雜質(zhì) single impurity

ii) 總雜質(zhì)total impurity

• 重金屬Heavy metals
• 干燥失重Loss on drying
• 灰分Sulphated ash
• 酸堿度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%