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Certificate Of Analysis
品 名 Product Name |
Progesterone |
批 號(hào) 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(yàn)日期 Test Date |
2020/06/03 |
|
有效日期 Exp. Date |
2022/06/02 |
標(biāo) 準(zhǔn) Standard |
USP32 |
|
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 |
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(guó)藥典USP32 This batch complies with USP32 |