ZAFA CHEMIE

A division of ZAFA pharmaceutical Laboratories (Pvt) Limited.

Doc #: ZC/QA/DMF-002 Rev #: 00 Review Date: 13-02-2019
Next Review Date: 12-02-2022
Title : DRUG MASTER FILE (DMF) Paracetamol B.P

ZAFA CHEMIE
A division of ZAFA pharmaceutical Laboratories (Pvt) Limited.
Doc #: ZC/QA/IMP-02 Rev #: 00 Review Date: 07-02-2019
Next Review Date: 06-02-2022
Title :  IMPURITIES OF PARACETAMOL B.P

Paracetamol Impurity A N-(2-hydroxyphenyl)acetamide

Paracetamol Impurity B N-(4-

hydroxyphenyl)propanamide

Paracetamol Impurity C N-(3-chloro-4-hydroxyphenyl)

acetamide

Paracetamol Impurity D Acetylaniline; N-

Phenylacetamide;N-
phenylcetamide ; Acetanilide

Paracetamol Impurity E 1-(4-hydroxyphenyl)ethan-1-one;

4-Hydroxyacetophenone

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 ZAFA CHEMIE
A division of ZAFA pharmaceutical Laboratories (Pvt) Limited.
Doc #: ZC/QA/DMF-002 Rev #: 00 Review Date: 13-02-2019
Next Review Date: 12-02-2022
Title : DRUG MASTER FILE (DMF) Paracetamol B.P

Paracetamol Impurity F p-Nitrophenol; 1-Hydroxy-4-

nitrobenzene

Paracetamol Impurity G 4-[1-

(hydroxyamino)ethylidene]cycloh
exa-2,5-dien-1- one

Paracetamol Impurity H N-[4-

(Acetyloxy)phenyl]acetamide

Paracetamol Impurity I 1-(2-hydroxyphenyl)ethan-1-one

Paracetamol EP Impurity J N-(4-Chlorophenyl)acetamide

4-Aminophenol/ Paracetamol p-Aminophenol; 1-Amino-4-

Impurity K hydroxybenzene

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