CERTIFICATE OF ANALYSIS

PRODUCT NAME: Amikacin EP Impurity D
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number AMK-004
Lot Number Sample COA
Batch Quantity Sample COA
CAS Number 59-01-8
Alternate CAS Number 64013-70-3(Sulfate - Salt);5965-95-7(Sulfate Hydra
Mol. Formula C18H36N4O11
Molecular Wt 484.5 g/mol
Long Term Storage Condition 2-8°C Refrigerator Handling instruction Sample COA
IUPAC (2R,3S,4S,5R,6R)-2-(Aminomethyl)-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
Chemical Name Amikacin EP Impurity D
Synonyms Kanamycin API; Amikacin Sulfate Impurity D (As per 35.1 EP Monograph); (2R,3S,4S,5R,6R)-2-(Aminomethyl)-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)tetrahydro-2H-pyran-3,4,5-triol;6-O-(3-Amino-3-deoxy-α-D-glucopyranosyl)-4-O-(6-amino-6-deoxy-α-D-glucopyranosyl)-2-deoxy-D-streptamine
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