China (Mainland)
LEVOFLOXACIN HEMIHYDRATE CAS NO.138199-71-0
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Keywords
- 138199-71-0
- LEVOFLOXACIN HEMIHYDRATE
- LEVOFLOXACIN
Quick Details
- ProName: LEVOFLOXACIN HEMIHYDRATE
- CasNo: 138199-71-0
- ProductionCapacity: Metric Ton/Day
- Purity: 99%min
- LimitNum: 0 Metric Ton
Superiority
Product Name: LEVOFLOXACIN HEMIHYDRATE
Packing: 1× 25Kg Batch No.: 20160610
Quantity: 50KGS Examined Basis: Reference USP34
Mfg. Date: JUN.10, 2016 Exp. Date: JUN.09, 2020
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检验项目（Tests） |
标准（Acceptance Criteria） |
结果（Results） |
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Description 性状 |
White or yellow light crystalline powder 白色或微黄色结晶粉末 |
Conform 符合规定 |
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Identification 鉴别 |
(1)IR：Conforms to the spectrum of Levofloxcain RS IR：红外吸收图谱应与对照品图谱一致 (2)HPLC：The retention time of the major peak of the sample solution corresponds to that of the standard solution,as obtained in the Assay. HPLC：在含量测定项目下，供试品溶液主峰保留时间应与对照品主峰保留时间一致 |
Conform 符合规定 |
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水分（Water） |
2.1%—2.7% |
2.7% |
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比旋度（Optical rotation） |
-92°～-106° |
-95.8° |
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炽灼残渣（Residue on ignition） |
≤0.2% |
0.05% |
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重金属（Heavy metals） |
≤10ppm |
Conform |
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Individual impurity 单个杂质 |
N-脱甲基左氧氟沙星 (N-Desmethyl levofloxacin) |
≤0.3 |
0.07% |
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二胺衍生物 (Diamine derivative) |
≤0.3 |
0.05% |
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左氧氟沙星 N-氧化物 (Levofloxacin N-oxide) |
≤0.3 |
0.03% |
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9-脱氟左氧氟沙星 (9-Desfluoro levofloxacin) |
≤0.3 |
0.10% |
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右旋异构体(D-Isomer) |
≤0.8 |
0.28% |
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未知杂质 (Any unknown impurity) |
≤0.1 |
Conform |
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Total impurity（Do not include D-Isomer ） 总杂(不包含右旋异构体) |
≤0.5% |
0.18% |
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*Residual solvents 残留溶剂 |
乙醇（Ethanol） |
≤0.5% |
Conform |
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DMF（Dimethyl Formamide） |
≤0.088% |
Conform |
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甲苯（Toluene） |
≤0.089% |
Conform |
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二甲基亚砜（Dimethyl sulfoxide） |
≤0.5% |
Conform |
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含量（Assay） |
98.5%～102.0% |
99.2% |
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Conclusion Conforms to USP34 specification for levofloxacin 结论 本品参照美国药典34版标准检验，结果符合规定 |
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