CERTIFICATE OF ANALYSIS

PRODUCT NAME: Amikacin EP Impurity A
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number AMK-002
Lot Number Sample COA
Batch Quantity Sample COA
CAS Number 50725-24-1
Mol. Formula C22H43N5O13
Molecular Wt 585.6 g/mol
Long Term Storage Condition 2-8°C Refrigerator Handling instruction Sample COA
IUPAC (2S)-4-Amino-N-[(1S,2R,3R,4S,5R)-5-amino-4-[(2S,3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-2-[(2R,3R,4S,5S,6R)-6-(aminomethyl)-
Chemical Name Amikacin EP Impurity A
Synonyms Amikacin Sulfate Impurity A (As per 35.1 EP Monograph); 3-HABA Kanamycin A; (S)-4-Amino-N-((1S,2R,3R,4S,5R)-5-amino-4-(((2S,3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)-2-(((2R,3R,4S,5S,6R)-6-(aminomethyl)-3,4,5-trihydroxytetrahydro-2H-pyran-2-yl)oxy)-3-hydroxycyclohexyl)-2-hydroxybutanamide; (2S)-4-Amino-N-[(1S,2R,3R,4S,5R)-5-amino-4-[(2S,3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-2-[(2R,3R,4S,5S,6R)-6-(aminomethyl)-3,4,5-trihydroxyoxan-2-yl]oxy-3-hydroxycyclohexyl]-2-hydroxybutanamide
Test Results
Appearance white to off-white crystalline or amorphous powder
Identification by 1H NMR Sample COA
Identification By IR Sample COA
Mass (ESI) Sample COA
Purity NLT 98%
Wt. Loss by TGA Sample COA
% Potency Sample COA
Solubility
QC Release Date Sample COA
Attachments 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