品    名

Product Name

 雌酚酮

Estroene

批    號(hào)

Batch No

20210312

批量

Batch Size

10.0kg

數(shù)    量

Quantity

5.0kg

生產(chǎn)日期

MFG. Date

2021/03/12

檢驗(yàn)日期

Test Date

20210312

有效日期

Exp. Date

2023/03/11

標(biāo)    準(zhǔn)

Standard

USP36

檢驗(yàn)項(xiàng)目Test Items

檢驗(yàn)指標(biāo)Specification

檢驗(yàn)結(jié)果

Test Results

性狀 Appearance

白色或類白色粉末

A white or almost white crystalline powder

符合規(guī)定

conform

鑒別

Identification

TLC

符合規(guī)定

conform

UV Spectrum

符合規(guī)定

conform

IR  Spectrum

符合規(guī)定

conform

溶液澄清

Clarity of solution

 溶液應(yīng)澄清

The solution is clear

符合規(guī)定

conform

比旋度Specific optical rotation

+158°~+165°

+162°

干燥失重

Loss on drying

≤0.5%

0.21%

灼燒殘?jiān)?/p>

Residue on ignition

≤0.5%

0.11%

馬奈雌酮與馬烯雌酮的限度

Limit of equenin and equilin

Meet the requirements

符合規(guī)定

conform

一般雜質(zhì)

Ordinary impourities

Meet the requirements

符合規(guī)定

conform

殘留溶劑

Residual solvents

Meet the requirements

符合規(guī)定

conform

硫酸鹽灰分

Sulphated ash

NMT0.2%

0.04%

含量Assay

97.0%~103.0%

99.30%

結(jié)論Conclusion

該產(chǎn)品符合USP36  This batch complies with USP36