品名Product Name

十一酸雌二醇Estradiol undecanoate   CAS:3571-53-7

生產(chǎn)日期

Manufacturing Date

2024/05/12

批號

Batch No.

202405001

有效期

Expiry Date

2026/05/11

數(shù)量

Quantity

500g

檢驗依據(jù)

Reference Standard

企標(biāo)

Company standard

包裝

Packing

100g/bag

檢驗項目

 TEST

質(zhì)量標(biāo)準(zhǔn)  

ACCEPTANCE CRITERIONS  

檢驗結(jié)果RESULTS

鑒別

Identification

A:IR   B:UV     C:TLC

B utraviolet absorption

Absorptivitles at 281nm,calculated on the dried dasis,do not differ by more than 3.0%

符合規(guī)定

Conform

符合規(guī)定

conform

性狀

Characteristics

白色粉末

White crystalline powder

符合規(guī)定

conform

溶解度solubility

不溶于水，溶于乙醇，丙酮、二氧六環(huán)、氯仿，微溶于植物油

,practiclly insoluble in water,Soluble in alcohol,acetone,dioxane,chloroform;sparingly soluble in vegetable oils.

符合規(guī)定

conform

熔點Melting point

About 110℃

109.8-110.6℃

比旋度

Specific rotation

﹢51.0°~﹢56.0°

﹢52.1°

含量Assay

97 .0~ 103.0%

99.50%

干燥失重

Loss on drying

≤0.50%

0.21%

雜質(zhì)總量

Total related substance

≤2.0%

0.38%

單一雜質(zhì)

Any individual impurity

≤0.50%

0.12%

灼燒殘渣

Residue ignition

≤0.10%

0.08%

純度Putity

≥99.0%

99.62%

結(jié)論 Conclusion

本品按企業(yè)標(biāo)準(zhǔn)檢驗，結(jié)果符合規(guī)定

Company standard,conform the stipulation.