品    名Product Name

鹽酸環(huán)丙沙星

Ciprofloxacin Hydrochloride

生產(chǎn)批號(hào)Lot no

200503

包裝容器Packing

紙板桶Fiber Drum

數(shù)量Quantity

6KG

生產(chǎn)日期MFG. Date

20200503

檢驗(yàn)日期

20200503

檢驗(yàn)依據(jù)

Quality Specification

USP30版USP30Edition

有效期EXP.Date

20220502

檢驗(yàn)項(xiàng)目Test Items

檢驗(yàn)指標(biāo)Specification

檢驗(yàn)結(jié)果Test Results

外觀Description

白色或類白色結(jié)晶性粉末

White or Off-White Crystalline Powder

CONFORM

溶解度Solubility

Meets the requirements

CONFORM

溶液顏色Colour of solution

Meets the requirements

CONFORM

氟喹諾酮酸

Fluoroquinoloic Acid（%）

≤0.2

<0.2

硫酸鹽Sulfate（%）

≤0.04

<0.04%

PH (lin40)

3.0~4.5

3.7

水分Water by K.F.(%)

4.7~6.7

6.0%

灼燒殘?jiān)?/p>

Resudue On Ignition

≤0.1

0.02%

重金屬Heavy Metals

≤0.002

<0.002

色譜純度

Chromatographic Purity

Meets the requirements

CONFORM

單一雜質(zhì)Single impurity

≤0.2

0.17%

其他但以雜質(zhì)

Any other individual impurities

≤0.2

<0.2%

總雜質(zhì)

Total impurities（%）

≤0.5

0.47%

含  量Assay（%）

98.0~102.0

99.3%

結(jié)   論Conclusion

檢驗(yàn)指標(biāo)符合USP30版 The Specification conform with USP30 Edition