CERTIFICATE OF ANALYSIS

PRODUCT NAME: Amikacin EP Impurity B
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number AMK-003
Item/Batch Number Sample COA
Quantity Sample COA
CAS Number 927821-99-6
Mol. Formula C26H50N6O15
Molecular Wt 686.7 g/mol
IUPAC (2S,2'S)-N,N'-((1S,3R,4S,5R,6R)-4-(((2S,3R,4S,5S,6R)-4-Amino-3,5-dihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)-6-(((2R,3R,4S,5S,6R)-6-(amin
Synonyms Amikacin Sulfate Impurity B (As per 35.1 EP Monograph); 1,3-Di-HABA Kanamycin A; (2S,2'S)-N,N'-((1S,3R,4S,5R,6R)-4-(((2S,3R,4S,5S,6R)-4-Amino-3,5-dihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)-6-(((2R,3R,4S,5S,6R)-6-(aminomethyl)-3,4,5-trihydroxytetrahydro-2H-pyran-2-yl)oxy)-5-hydroxycyclohexane-1,3-diyl)bis(4-amino-2-hydroxybutanamide);O-3-Amino-3-deoxy-α-D-glucopyranosyl-(1→6)-O-[6-amino-6-deoxy-α-D-glucopyranosyl-(1→4)]-N1,N3-bis[(2S)-4-amino-2-hydroxy-1-oxobutyl]-2-deoxy-D-streptamine
Long Term Storage Condition 2-8°C Hygroscopic, Refrigerator, Under Inert Atmosphere
Handling instruction Sample COA
Test Results
Appearance White Solid
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