UNICHEM PHARMACEUTICALS PAKISTAN (PVT) LIMITED

Doc #:UPP/QC/FP/IMP- 004 Rev #: 00 Preparation Date: 03-07-2020

Next Review Date:02-07-2023
Title : IMPURITIES OF CEFIXIME TRIHYDRATE

CEFIXIME 2-[[(Z)-2-(2-aminothiazol-4-
Impurity A yl)-2-
[(carboxymethoxy)imino]ac
etyl]amino]-2-[(2R)-5-
methyl-7-oxo-1,2,5,7-
tetrahydro-4H-furo[3,4-d]
[1,3]thiazin-2-yl]acetic acid,

CEFIXIME 2-[[[(Z)-1-(2-aminothiazol-
Impurity B 4-yl)-2-[[[(2R,5RS)-5-
methyl-7-oxo-1,2,5,7-
tetrahydro-4H-furo[3,4-d]
[1,3]thiazin-2-
yl]methyl]amino]-2-
oxoethylidene]amino]oxy]ac
etic acid,

CEFIXIME . (6R,7S)-7-[[(Z)-2-(2-
Impurity C aminothiazol-4-yl)-2-
[(carboxymethoxy)imino]ac
etyl]amino]-3-ethenyl-8-
oxo5-thia-1-
azabicyclo[4.2.0]oct-2-ene-
2-carboxylic acid (cefixime
7-epimer),

CEFIXIME . (6R,7R)-7-[[(E)-2-(2-
Impurity D aminothiazol-4-yl)-2-
[(carboxymethoxy)imino]ac
etyl]amino]-3-ethenyl-8-
oxo5-thia-1-
azabicyclo[4.2.0]oct-2-ene-
2-carboxylic acid (cefixime
(E)-isomer),

CEFIXIME (6R,7R)-7-[[(Z)-2-(2-
Impurity E aminothiazol-4-yl)-2-
[(carboxymethoxy)imino]ac
etyl]amino]-3-methyl-8-
oxo-5-thia-1-
azabicyclo[4.2.0]oct-2-ene-
2-carboxylic acid,

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 UNICHEM PHARMACEUTICALS PAKISTAN (PVT) LIMITED
Doc #:UPP/QC/FP/IMP- 004 Rev #: 00
Preparation Date: 03-07-2020
Next Review Date:02-07-2023
Title : IMPURITIES OF CEFIXIME TRIHYDRATE

CEFIXIME . (6R,7R)-7-[[(Z)-2-(2-
Impurity F aminothiazol-4-yl)-2-[(2-
ethoxy-2-
oxoethoxy)imino]acetyl]ami
no]-3-ethenyl-8-oxo-5-thia-
1-azabicyclo[4.2.0]oct-2-
ene-2-carboxylic acid

Prepared By Reviewed By Approved By

Quality Control Manager Plant Manager Chief Executive Officer

Date: Date: Date:

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