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1. CERTIFICATE OF ANALYSIS
AZITHROMYCIN IMPURITY B
Product Name AZITHROMYCIN IMPURITY B
Chemical Name 3-deoxy azithromycin
Mol. Formula C38H72N2O11
Mol. Weight 733.01g/mol
Batch No Ax-IMP066 Analysis Date 28-Apr-16
Quantity 25MG Retest Date Apr-17
Storage
S.N. Test
1 Appearance
2 Solubility
3 Identification by 1H NMR
4 Identification by Mass
5 Purity by HPLC
Remarks:
Approved by
Sign.
Date:
FRM/007-00 Quality Control Department
Preserve in Air tight container, protect from direct sunlight and for longer storage store at 2-8 C.
Result
White Solid
Freely Soluble in Methanol
Complies
Complies
99.77%
Based on 1H NMR, Mass and HPLC data, material confirms to the above product.
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