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分析證明
Certificate of Analysis
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品名 Product Name |
醋酸炔諾酮 Norethindrone acetate |
數(shù)量 Batch Size |
Sample |
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生產(chǎn)日期 Manufacturing Date |
2023.04.28 |
批號(hào) Batch No. |
20230428 |
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有效期 Expiry Date |
2027.04.27 |
報(bào)告日期 Report Date |
2023.05.06 |
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檢驗(yàn)依據(jù) Reference Standard |
美國(guó)藥典34版 USP34 |
包裝 Packing |
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檢驗(yàn)項(xiàng)目 TEST |
質(zhì)量標(biāo)準(zhǔn) SPECIFICATIONS |
檢驗(yàn)結(jié)果 RESULTS |
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鑒別 Identification |
TLC |
正性反應(yīng) Positive |
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UV spectrum |
Positive |
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IR spectrum |
Positive |
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性狀 Characteristics |
白色或淡黃色結(jié)晶性粉末 White or yellowwish-white,crystalline powder |
符合規(guī)定 Conform |
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比旋度 Specific roation |
-32°～-38° |
-32.5° |
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干燥失重 Loss on drying |
≤0.5% |
0.20% |
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含量 Assay |
97.0~ 103.0％ |
99.49% |
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乙炔基限量 Limit of ethynyl group |
7.13%~ 7.57% |
合格 pass |
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有關(guān)物質(zhì) Related substances |
Any individual impurity ≤0.5% Total impurities ≤1.0% |
合格 Pass |
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結(jié)論 Conclusion |
本批號(hào)符合美國(guó) 藥典34 版 This batch complies with USP34 |
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復(fù)核人 Supervisor |
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分析人 Analyst |
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