Product name

Ivermectin

Inspect Date

檢驗日期

14th,Aug,2023

品   名

伊維菌素

2023年8月14日

Batch NO.

20230814

Report date

報告日期

14th,Aug,2023

批   號

2023年8月14日

Inspect as

EP8

Retest Date

復(fù)檢日期

13th,Aug,2025

檢驗依據(jù)

2025年8月13日

Inspect item

Inspect standard

Inspect conclusion

Conclusion

檢驗項目

檢 驗 標(biāo) 準(zhǔn)

檢 驗 結(jié) 果

單項結(jié)論

Characters

性  狀

Should be white or yellowish-crystalline powder

應(yīng)為白色或微黃色結(jié)晶性粉末

White-crystalline powder

白色結(jié)晶性粉末

Conform

符合規(guī)定

 IR

紅外線

Should be corresponds with that of CRS standard

應(yīng)與CRS標(biāo)準(zhǔn)品的圖譜一致

Corresponds with that of CRS standard

與CRS標(biāo)準(zhǔn)品的圖譜一致

Conform

符合規(guī)定

HPLC

液相鑒別

Should be corresponds with retention time  of CRS standard  

應(yīng)與標(biāo)準(zhǔn)品保留時間一致

Corresponds  with that of CRS standard

與標(biāo)準(zhǔn)品一致

Conform

符合規(guī)定

Specific rotation

比旋度

-17º~-20º

-18.2º

Conform

符合規(guī)定

Water

水分

≤1.0%

0.5%

Conform

符合規(guī)定

Appearance of solution

溶液外觀

Should be clear and not more intensely colored than BY₇

應(yīng)澄清，溶液顏色不深于BY₇

Clear

澄清

Conform

符合規(guī)定

H₂B_1a/(H₂B_1a+H₂B_1b)

H₂B_1a

≥90.0%

97.5%

Conform

符合規(guī)定

Related substances

相關(guān)物質(zhì)

Individual impurities(RRT1.3-1.5)≤2.5%

單一雜質(zhì)（RRT1.3-1.5）≤2.5%

2.2%

Conform

符合規(guī)定

Any other individual impurities ≤1%

其他單一雜質(zhì)≤1%

0.65% 0.23% 0.49%

0.14% 0.46% 0.20%

Conform

符合規(guī)定

Total impurities ≤5%  

雜質(zhì)總和≤5%

4.5

Conform

符合規(guī)定

Disregard limit ≤0.05%

檢測限≤0.05%

0.05%

Conform

符合規(guī)定

Ethanol

乙醇

≤5.0%

3.9

Conform

符合規(guī)定

Heavy metal

重金屬

≤0.002%

＜0.001%

Conform

符合規(guī)定

Formamide

甲酰胺

≤3.0%

2.7%

Conform

符合規(guī)定

Sulphated ash

硫酸灰分

≤0.1%

0.05%

Conform

符合規(guī)定

Assay

含量

Should be 95.0%-102.0%

應(yīng)為95.0%-102.0%

95.9%

Conform

符合規(guī)定

The conclusion: This  product conform the standard requirement of EP8 standard.

結(jié)論：經(jīng)檢驗，本品符合EP8標(biāo)準(zhǔn)的規(guī)定