CERTIFICATE OF ANALYSIS

AZITHROMYCIN IMPURITY B
Product Name

AZITHROMYCIN IMPURITY B

Chemical Name

3-deoxy azithromycin

Mol. Formula
Mol. Weight

C38H72N2O11
733.01g/mol

Batch No Ax-IMP066

Analysis Date

28-Apr-16

Quantity 25MG

Retest Date

Apr-17

Storage

Preserve in Air tight container, protect from direct sunlight and for longer storage store at 2-8 C.

S.N.

Test

Result

Appearance

White Solid

Solubility

Freely Soluble in Methanol

Identification by 1H NMR

Complies

Identification by Mass

Complies

Purity by HPLC

99.77%

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