品    名

Product Name

 Progesterone

批    号

Batch No

20200603

批量

Batch Size

10.0kg

数    量

Quantity

5.0kg

生产日期

MFG. Date

2020/06/03

检验日期

Test Date

2020/06/03

有效日期

Exp. Date

2022/06/02

标    准

Standard

USP32

检验项目Test Items

检验指标Specification

检验结果

Test Results

性状 Appearance

白色或类白色粉末

A white or almost white crystalline powder

符合规定

conform

鉴别

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%

残留溶剂

Residual solvents

Meet the requirements

符合规定

conform

含量Assay

97.0%~103.0%

99.52%

结论Conclusion

该产品符合美国药典USP32  This batch complies with USP32