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CERTIFICATE OF ANALYSIS Reference Substance

Date

Azithromycin Impurity E Batch No. IUPAC Name: 3’-(N,N-didesmethyl)azithromycin,aminoazithromycin H 3C HO HO H 3C H3 C

CH 3

N CH 3

OH HO CH 3 O

H3C O O

O CH 3

O

NH 2 O CH3 OCH3 CH 3 OH CH 3

Molecular Weight: 720.93 Molecular Formula: C36H68N2O12 Sr.# 1 2 3 4 5 6

Test Appearance Purity by HPLC Mass NMR TGA IR

Results

white solid 97.38% Conform Conform for Information Conform

Data ref.

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Storage condition: Store at refrigerator, protect from direct sunlight. For Long term storage: 2-8°C, Shipment date: This certificate of analysis is valid for two years from date of manufacturing provided the substance is stored under suitable conditions. Date of manufacturing: Retest Date: Document data reference:

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Azithromycin impurity e