Product Name  产品名称

Paroxetine hydrochloride hemihydrate盐酸帕罗西汀

Batch Number  批    号

20221222

Quantity    数    量

80Kg

Production Site 生产场地

Paroxetine HCl workshop

Specification规    格

5Kg/tin

Production Date生产日期

2022.12.22

Retest Date  复验日期

2024.12.21

Certificate No.  报告编号

2022122201

Report Date  报告日期

2022.12.22

Contents

项  目

Specification: EP7.0

标  准：EP7.0

Results of analysis

检验结果

Appearance

性状

White or almost white crystalline powder

白色或类白色结晶性粉末

类白色结晶性粉末

Almost white crystalline powder

Identification

鉴别

• Comparing with the spectrum obtained with CRS   

红外光吸收图谱应与对照品图谱相一致

Conform  符合

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

供试品溶液的主峰面积和保留时间应与对照品溶液的相一致

Conform  符合

• Water (by KF)   水分（卡尔-费休氏）

Conform  符合

• Reaction of chlorides 氯化物反应

Conform  符合

Impurity D

杂质D

≤0.2%

未检出

Related substances

有关物质

• Impurity A: not more than 0.3%   

杂质A：不得超过0.3%

0.03%

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

未指定杂质：均不得超过0.10%

0.06%

• Total impurities: not more than 0.5%

总杂质：不得超过0.5%

0.1%

Heavy metals

重金属 

≤0.002%

＜0.002%

Water

水分

2.2%~2.7%

2.46%

Sulfated ash 

硫酸盐灰分

≤0.1%

＜0.1%

Assay(anhydrous substance)

含量（无水物）

97.5%~102.0%

100.2%

Residual solvents

残留溶剂

Meets the requirements

符合规定

Conform  符合

 Conclusion: Conforming to EP7.0.    结论：符合EP7.0。