品    名

Product Name

左旋氧氟沙星

levofloxacin

数    量

Quantity

100kg

批    号

Batch No

20211213

报告日期

Report Date

2021.12.13

生产日期

MFG. Date

2021.12.13

有 效 期

Exp. Date

2023.12.12

检验项目

Test Items

检验指标

Specification

检验结果

Test Results

外观Appearance

浅黄色或黄色结晶性粉末Light yellow or yellowish white crystalline powder

符合规定Conform

溶解度Solubility

溶于三氯甲烷，微溶于甲醇和水Soluble in chloroform, slightly soluble in methanol and water

符合规定Conform

鉴别 Identification

红外光吸收图谱应与对照品的图谱一致IR Similar to standard

符合规定Conform

溶液的澄清度

Solution Clarity

Clear

符合规定Conform

溶液的颜色

Solution Color

≤0.025

0.0065

比旋度

Specific rotation

-95^o～-103^o

-97.2^o

干燥失重

Loss on drying

≤3.0%

2.47%

炽灼残渣

Residue on ignition

≤0.2%

0.04%

右旋体Limit nf(R)-oflx

≤0.5%

0.10%

重金属Heavy metal

≤20ppm

符合规定Conform

有关物质Related substances

单个杂质：individual impurity≤0.2%

总杂质:total impurity≤0.5%

0.10%

0.22%

含量Assay

≥98.5%

99.2%

检验结论Conclusion

符合企业标准规定 Conform to Enterprise Standard