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CERTIFICATE OF ANALYSIS

AZITHROMYCIN IMPURITY O
Product NameAZITHROMYCIN IMPURITY O
Chemical Nam2-desethyl-2-propylazithromycin
Mol. Formula C39H75N2O12
Mol. Weight 764.04g/mol
Batch NAx-IMP084

Analysis Date28-Apr-16

Quantit 25MG

Retest Date Apr-17

StoragePreserve in Air tight container, protect from direct sunlight and for longer storage store at
S.N.

Test

Result

Appearance

White Solid

Solubility

Freely Soluble in Methanol

Identification by 1H NMR

Complies

Identification by Mass

Complies

Purity by HPLC

96.51%

Remarks
Based on 1H NMR, Mass and HPLC data, material confirms to the above product.
Prepared By

Approved by

Sign.
Date:
FRM/007-00

Quality Control Department

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