PRODUCT NAME: Amikacin EP Impurity D
Date of Mfg: Sample COA	RETEST DATE: Sample COA

Catalogue Number	AMK-004
Item/Batch Number	Sample COA
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
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
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
Long Term Storage Condition	2-8°C Refrigerator
Handling instruction	Sample COA

Test	Results
Appearance	white to off-white crystalline or 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