CERTIFICATE OF ANALYSIS

PRODUCT NAME: Amikacin EP Impurity F
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number AMK-010
Item/Batch Number Sample COA
Quantity Sample COA
CAS Number 197909-67-4
Alternate CAS Number NA(Sulphate Salt)
Mol. Formula C26H50N6O15
Molecular Wt 686.7 g/mol
IUPAC (S)-4-Amino-N-((1R,2S,3S,4R,5S)-5-amino-4-(((2R,3R,4S,5S,6R)-6-(((S)-4-amino-2-hydroxybutanamido)methyl)-3,4,5-trihydroxytetrahydro-2H-pyran-2-yl)oxy)
Synonyms Amikacin Sulfate Impurity F (As per 35.1 EP Monograph); 1,6'-Di-HABA Kanamycin A; (S)-4-Amino-N-((1R,2S,3S,4R,5S)-5-amino-4-(((2R,3R,4S,5S,6R)-6-(((S)-4-amino-2-hydroxybutanamido)methyl)-3,4,5-trihydroxytetrahydro-2H-pyran-2-yl)oxy)-2-(((2S,3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)-3-hydroxycyclohexyl)-2-hydroxybutanamide
Long Term Storage Condition -20°C or lower
Handling instruction Sample COA
Test Results
Appearance white to off-white amorphous powder
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%
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