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品名 |
左炔諾孕酮 |
數(shù)量 |
100g |
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Product Name |
Levonorgestrel |
Batch Size |
100g |
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生產(chǎn)日期 |
2022.06.16 |
批號 |
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Manufacturing Date |
2022.06.16 |
Batch No. |
20220616 |
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有效期 |
2025.11.15 |
報告日期 |
2022.06.23 |
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Expiry Date |
2025.11.15 |
Report Date |
2022.06.23 |
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檢驗依據(jù) |
美國藥典 32版 |
包裝 |
1kg/鋁箔袋 |
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Reference Standard |
USP 32 |
Packing |
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檢驗項目 |
質(zhì)量標準 |
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檢驗結(jié)果 |
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TEST |
ACCEPTANCECRITERIONS |
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RESULTS |
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正性反應 |
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鑒別 |
TLC |
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Positive |
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Identification |
UV spectrum |
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Positive |
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IR spectrum |
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Positive |
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性狀 |
白色或類白色結(jié)晶性粉末 |
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符合規(guī)定 |
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Characteristics |
White or yellowishcrystallineowder |
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conform |
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熔點 |
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Melting point |
232 ~ 239℃ |
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234~237.5℃ |
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干燥失重 |
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Loss on drying |
≤0.5% |
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0.21% |
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比旋度 |
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Specific rotation |
–30~ –35° |
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-33° |
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乙炔基 |
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Limit of ethinyl group |
7.81~8.18% |
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7.98% |
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殘留溶劑 |
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合格 |
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Residual Solvents |
ethanol≤0.5% |
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Pass |
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其它甾體 |
sum of the impurities≤2.0％ |
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合格 |
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Other sterold |
single impurity ≤0.5％ |
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Pass |
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熾灼殘渣 |
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Residue on ignition |
≤0.3％ |
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0.19% |
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含量 |
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Assay |
98.0～102.0％ |
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99.16% |
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結(jié)論 |
本批號符合 美國藥典 32版 |
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Conclusion |
This batch complies with USP 32 |
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復核人 |
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分析人 |
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Supervisor |
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Analyst |
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