品    名

Product Name

硝酸咪康唑

Econazole Nitrate

批    號

Batch No

20191008

數(shù)    量

Quantity  

200kgs

包    裝

Packing

25kgs/紙板桶

25kgs/drum

生產(chǎn)日期

MFG. Date

2019.10.08

有 效 期

Exp Date

2021.10.07

檢驗項目

Test Items

檢驗指標(biāo)

Specification

檢驗結(jié)果

Test Results

外觀Appearance

白色或類白色結(jié)晶粉末

White or Almost white powder

符合規(guī)定

Complies

鑒別

Identification

紅外光譜吸收

IR

與標(biāo)準(zhǔn)相近Similar to standard

符合規(guī)定

Complies

溶液澄清度

Appearance of Solution

溶液清澈，色澤不深于標(biāo)準(zhǔn)液

The solution is clear and not more intensely cloured than reference solutions

符合規(guī)定

Complies

溶解性Solubility

難溶于水，溶于甲醇，微溶于乙醇

Very slightly soluble in water; soluble in methanol ; slightly soluble in alcohol

符合規(guī)定

Complies

旋光度

Angle of optical rotation

-0.1^o～+0.1^o

符合規(guī)定

Complies

相關(guān)物質(zhì)(HPLC) Related Substances

單個雜質(zhì)

Each Impurity

≤0.25%

0.18%

雜質(zhì)總和

Total Impurity

≤0.5%

0.25%

熔點Melting Point

163～167℃

164.5℃

干燥失重Loss on Drying

≤0.5%（105℃2小時）

0.32%

熾灼殘渣Residue on Ignition

≤0.1%

0.01%

含量（干基）Assay (on dry basis)

98.0～102.0%

99.38%

結(jié)論

Conclusion

本品符合USP35/BP2007標(biāo)準(zhǔn)

Conform to the specification of USP35/BP2007