品    名Product Name

酮洛芬ketoprofen

批    號Batch No

20201215

生產(chǎn)日期MFG. Date

2020.12.15

出廠日期Sale Date

2020.12.15

有效期Expiry date

3年3 years

重量Quantity

6.0kg

檢驗(yàn)項(xiàng)目Test Items

檢驗(yàn)指標(biāo)Specification

檢驗(yàn)結(jié)果Test Results

鑒別

Identification

A.熔點(diǎn)melting point

94-97 ℃

95.0℃

B.紫外吸收光譜UV

255nm處有最大吸收（max=255nm）,E^1%_1CM=615-680

254nm處有最大吸收（max=255nm）,E^1%_1CM=676

C.紅外吸收光譜IR

與對照品圖譜一致，corresponding to reference spectrum

與對照品圖譜一致，corresponding to reference spectrum

D 薄層色譜TCL

與對照品R1值一致，corresponding to reference R1

與對照品R1值一致，corresponding to reference R1

澄清度Clarity

澄清（≤Ref.Susp.I）,clear

澄清（≤Ref.Susp.I）,clear

顏色color

不深于對照液，≤Y6

不深于對照液，≤Y6

有關(guān)物質(zhì)

雜質(zhì)impurityC

雜質(zhì)impurityE

雜質(zhì)impurityB

雜質(zhì)impurityD

雜質(zhì)impurityA

雜質(zhì)impurityF

其他單個雜質(zhì)

Any other impurity

除雜質(zhì)A和C外，其他雜質(zhì)總和apart from A and C,other total

≤0.2%

≤0.2%

≤0.2%

≤0.2%

≤0.2%

≤0.2%

≤0.10%

≤0.4%

≤0.05%

≤0.05%

≤0.05%

≤0.05%

≤0.05%

≤0.05%

≤0.05%

≤0.05%

含量（on dried basis） %  Assay

99.0～100.5%

99.8%

水分 %

Water

＜0.5%

≤0.05%

重金屬 %

Heavy metals

≤10ppm

＜10ppm

硫酸化灰分sulphated ash

≤0.1%

≤0.04%

結(jié)論

Conclusion

符合藥典USP36版

Comply with USP36