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项目 Items |
标准 Specification |
结果 Results |
检测方法 Method |
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外观Appearance |
黄色到橙黄色的结晶粉末。Yellow to orange yellow crystalline powder. |
符合 Complies |
视觉Visual |
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鉴别Identification A.红外光谱 IR B.化学反应 Chemical reaction |
A:应与对照图谱一致 Should be consistent with the reference map |
符合 Complies |
USP<197K> |
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B: 应呈正反应 A blue color appears |
符合 Complies |
USP |
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水分Water |
≤0.2% |
0.04% |
USP<921>IC |
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炽灼残渣Residue on ignition |
≤0.1% |
0.01% |
USP<281>IC |
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粒径Particle Size |
90%过80目 90% pass through 80 meshes. |
95.7% |
USP<786> |
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含量Assay (on the anhydrous basis) |
98.0%-101.0% |
99.2% |
USP<621> |
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有关物质Related Substances |
辅酶 Q7,Q8,Q9,Q11和有关物质 Coenzymes Q7,Q8,Q9,Q11 and Related impurities |
≤1.0% |
0.64% |
USP<621> |
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2Z异构体和有关物质2Z Isomerand Related impurities |
≤1.0% |
0.26% |
USP<621> |
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总杂质Total impurities |
≤1.5% |
0.90% |
USP<621> |
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有机溶剂残留量Residual Solvents |
甲醇 Methanol |
≤3000ppm |
20.2ppm |
USP<467> |
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乙醇 Ethanol |
≤5000ppm |
36.9ppm |
USP<467> |
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正己烷 N-Hexane |
≤290ppm |
0.2ppm |
USP<467> |
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异丙醚 Isopropyl ether |
≤300ppm |
未检出 No detected |
USP<467> |
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重金属总量Total heavy metals |
无机砷As(Inorganic) |
≤1.5ppm |
＜1.5 ppm |
USP<2232> |
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镉Cd |
≤0.5ppm |
＜0.5 ppm |
USP<2232> |
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铅Pb |
≤0.5ppm |
＜0.5 ppm |
USP<2232> |
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总汞Hg |
≤1.5 ppm |
＜1.5 ppm |
USP<2232> |
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微生物检测 Microbiological tests |
需氧菌总数 Total aerobic microbial count |
≤1000 cfu/g |
＜10 cfu/g |
USP<2021> |
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霉菌和酵母菌 Total yeast and mold count |
≤50 cfu/g |
＜10 cfu/g |
USP<2021> |
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大肠埃希菌 Escherichia coli |
不得检出 Absent |
未检出 No detected |
USP<2022> |
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沙门氏菌Salmonella |
不得检出 Absent |
未检出 No detected |
USP<2022> |
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金黄色葡萄球菌Staphylococcus aureus |
不得检出 Absent |
未检出 No detected |
USP<2022> |
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储存Storage |
保存在密闭良好、耐光的容器中，不超过25℃。不要远离阳光直射和热源。 Preserve in well-closed, light-resistant containers, not more than 25℃.Keep it out ofdirect sunlight and away from heat source. |
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