CERTIFICATE OF ANALYSIS

PRODUCT NAME: Amikacin Impurity 1
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number AMK-015
Item/Batch Number Sample COA
Quantity Sample COA
CAS Number 50866-72-3
Mol. Formula C22H43N5O13
Molecular Wt 585.6 g/mol
IUPAC (S)-4-amino-N-(((2R,3S,4S,5R,6R)-6-(((1R,2R,3S,4R,6S)-4,6-diamino-3-(((2S,3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl
Synonyms Amikacin Sulfate Impurity E (As per 35.1 EP Monograph); 6-O-(6-amino-6-deoxy-a-D-glucopyranosyl)-4-O-[5-[[(2S)-4-amino-2-hydroxybutanoyl]amino]-3-deoxy-a-Dglucopyranosyl]-2-deoxy-D-streptamine; (S)-4-Amino-N-(((2R,3S,4S,5R,6R)-6-(((1R,2R,3S,4R,6S)-4,6-diamino-3-(((2S,3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)-2-hydroxycyclohexyl)oxy)-3,4,5-trihydroxytetrahydro-2H-pyran-2-yl)methyl)-2-hydroxybutanamide
Long Term Storage Condition 2-8°C Refrigerator
Handling instruction Sample COA
Test Results
Appearance white or off-white, crystalline 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