CERTIFICATE OF ANALYSIS

PRODUCT NAME: Clarithromycin EP Impurity B
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number CLR-004
Item/Batch Number Sample COA
Quantity Sample COA
CAS Number 299409-85-1
Mol. Formula C37H67NO13
Molecular Wt 733.93
IUPAC tetrabenzyl 14-[(5,6-difluoro-1,3-dioxoinden-2-ylidene)methyl]-6-[(5,6-difluoro-1-hydroxy-3-oxo-1H-inden-2-ylidene)methyl]-3,7,13-trithiapentacyclo[9.
Synonyms (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-6-(((2S,3R,4S,6R)-4-(Dimethylamino)-3-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-12,13-dihydroxy-4-(((2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl)oxy)-7-methoxy-3,5,7,9,11,13,14-heptamethyloxacyclotetradecane-2,10-dione; Erythromycin, 13-deethyl-13-methyl-6-O-methyl-; 13-Deethyl-13-methyl-6-O-methylerythromycin; 15-Norclarithromycin; USP Clarithromycin Impurity B; 6-O-Methyl-15-norerythromycin A (USP)
Long Term Storage Condition 2-8°C Refrigerator
Handling instruction Sample COA
Test Results
Appearance
Water content by KF/TGA Sample COA
% Potency = [100 - (Water content by KF)] X HPLC Purity)] / 100 Sample COA
Identification by HNMR Sample COA
Identification By IR Sample COA
Mass (ESI) Sample COA
Solubility
Purity NLT 98 % By HPLC
Analysis Date (Release Date) Sample COA
Attachments Sample COA
Other Information Sample COA
Note: This material can be used as a referance standard and is for research purpose ONLY and not for human consumption
This is Sample COA