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品 名 Product Name |
雌酚酮 Estroene |
批 號(hào) Batch No |
20210312 |
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批量 Batch Size |
10.0kg |
數(shù) 量 Quantity |
5.0kg |
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生產(chǎn)日期 MFG. Date |
2021/03/12 |
檢驗(yàn)日期 Test Date |
20210312 |
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有效日期 Exp. Date |
2023/03/11 |
標(biāo) 準(zhǔn) Standard |
USP36 |
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檢驗(yàn)項(xiàng)目Test Items |
檢驗(yàn)指標(biāo)Specification |
檢驗(yàn)結(jié)果 Test Results |
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性狀 Appearance |
白色或類白色粉末 A white or almost white crystalline powder |
符合規(guī)定 conform |
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鑒別 Identification |
TLC |
符合規(guī)定 conform |
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UV Spectrum |
符合規(guī)定 conform |
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IR Spectrum |
符合規(guī)定 conform |
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溶液澄清 Clarity of solution |
溶液應(yīng)澄清 The solution is clear |
符合規(guī)定 conform |
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比旋度Specific optical rotation |
+158°~+165° |
+162° |
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干燥失重 Loss on drying |
≤0.5% |
0.21% |
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灼燒殘?jiān)?/p> Residue on ignition |
≤0.5% |
0.11% |
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馬奈雌酮與馬烯雌酮的限度 Limit of equenin and equilin |
Meet the requirements |
符合規(guī)定 conform |
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一般雜質(zhì) Ordinary impourities |
Meet the requirements |
符合規(guī)定 conform |
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殘留溶劑 Residual solvents |
Meet the requirements |
符合規(guī)定 conform |
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硫酸鹽灰分 Sulphated ash |
NMT0.2% |
0.04% |
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含量Assay |
97.0%~103.0% |
99.30% |
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結(jié)論Conclusion |
該產(chǎn)品符合USP36 This batch complies with USP36 |
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