品    名

Product Name

 Progesterone

批    號

Batch No

20200603

批量

Batch Size

10.0kg

數(shù)    量

Quantity

5.0kg

生產(chǎn)日期

MFG. Date

2020/06/03

檢驗日期

Test Date

2020/06/03

有效日期

Exp. Date

2022/06/02

標    準

Standard

USP32

檢驗項目Test Items

檢驗指標Specification

檢驗結(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

IR

Positive

UV Spectrum

Positive

干燥失重

Loss on drying

≤0.5%

0.14%

Specific Rotation

+175~+183°

+179.1°

Related Substances

Any impurity: 0.5%max

Total impurities: 0.8%max

<0.5%

0.75%

殘留溶劑

Residual solvents

Meet the requirements

符合規(guī)定

conform

含量Assay

97.0%~103.0%

99.52%

結(jié)論Conclusion

該產(chǎn)品符合美國藥典USP32  This batch complies with USP32