Product Name  產(chǎn)品名稱

Paroxetine hydrochloride hemihydrate鹽酸帕羅西汀

Batch Number  批    號

20221222

Quantity    數(shù)    量

80Kg

Production Site 生產(chǎn)場地

Paroxetine HCl workshop

Specification規(guī)    格

5Kg/tin

Production Date生產(chǎn)日期

2022.12.22

Retest Date  復(fù)驗(yàn)日期

2024.12.21

Certificate No.  報告編號

2022122201

Report Date  報告日期

2022.12.22

Contents

項(xiàng)  目

Specification: EP7.0

標(biāo)  準(zhǔn)：EP7.0

Results of analysis

檢驗(yàn)結(jié)果

Appearance

性狀

White or almost white crystalline powder

白色或類白色結(jié)晶性粉末

類白色結(jié)晶性粉末

Almost white crystalline powder

Identification

鑒別

• Comparing with the spectrum obtained with CRS   

紅外光吸收圖譜應(yīng)與對照品圖譜相一致

Conform  符合

• The principal peak obtained with the test solution is similar in retention and size to that obtained with the reference solution   

供試品溶液的主峰面積和保留時間應(yīng)與對照品溶液的相一致

Conform  符合

• Water (by KF)   水分（卡爾-費(fèi)休氏）

Conform  符合

• Reaction of chlorides 氯化物反應(yīng)

Conform  符合

Impurity D

雜質(zhì)D

≤0.2%

未檢出

Related substances

有關(guān)物質(zhì)

• Impurity A: not more than 0.3%   

雜質(zhì)A：不得超過0.3%

0.03%

• Unspecified impurities: For each impurity, not more than 0.10 %

未指定雜質(zhì)：均不得超過0.10%

0.06%

• Total impurities: not more than 0.5%

總雜質(zhì)：不得超過0.5%

0.1%

Heavy metals

重金屬 

≤0.002%

＜0.002%

Water

水分

2.2%~2.7%

2.46%

Sulfated ash 

硫酸鹽灰分

≤0.1%

＜0.1%

Assay(anhydrous substance)

含量（無水物）

97.5%~102.0%

100.2%

Residual solvents

殘留溶劑

Meets the requirements

符合規(guī)定

Conform  符合

 Conclusion: Conforming to EP7.0.    結(jié)論：符合EP7.0。