品    名

Product Name

左旋氧氟沙星

levofloxacin

數(shù)    量

Quantity

100kg

批    號

Batch No

20211213

報告日期

Report Date

2021.12.13

生產(chǎn)日期

MFG. Date

2021.12.13

有 效 期

Exp. Date

2023.12.12

檢驗項目

Test Items

檢驗指標

Specification

檢驗結(jié)果

Test Results

外觀Appearance

淺黃色或黃色結(jié)晶性粉末Light yellow or yellowish white crystalline powder

符合規(guī)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

符合規(guī)定Conform

鑒別 Identification

紅外光吸收圖譜應(yīng)與對照品的圖譜一致IR Similar to standard

符合規(guī)定Conform

溶液的澄清度

Solution Clarity

Clear

符合規(guī)定Conform

溶液的顏色

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%

熾灼殘渣

Residue on ignition

≤0.2%

0.04%

右旋體Limit nf(R)-oflx

≤0.5%

0.10%

重金屬Heavy metal

≤20ppm

符合規(guī)定Conform

有關(guān)物質(zhì)Related substances

單個雜質(zhì)：individual impurity≤0.2%

總雜質(zhì):total impurity≤0.5%

0.10%

0.22%

含量Assay

≥98.5%

99.2%

檢驗結(jié)論Conclusion

符合企業(yè)標準規(guī)定 Conform to Enterprise Standard