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

Catalogue Number	AMK-006
Item/Batch Number	Sample COA
Quantity	Sample COA
CAS Number	48237-20-3
Alternate CAS Number	NA(Sulphate Salt)
Mol. Formula	C22H44N6O12
Molecular Wt	584.6 g/mol
IUPAC	(S)-4-Amino-N-((1R,2S,3S,4R,5S)-5-amino-2-(((2S,3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)-4-(((2R,3R,4R,5S,6R)
Synonyms	Amikacin Sulfate Impurity H (As per 35.1 EP Monograph); Amikacin B; 6-O-(3-amino-3-deoxy-a-D-glucopyranosyl)-4-O-(2,6-diamino2,6-dideoxy-a-D-glucopyranosyl)-1-N-[(2S)-4-amino-2-hydroxybutanoyl]-2-deoxy-D-streptamine; (S)-4-Amino-N-((1R,2S,3S,4R,5S)-5-amino-2-(((2S,3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)-4-(((2R,3R,4R,5S,6R)-3-amino-6-(aminomethyl)-4,5-dihydroxytetrahydro-2H-pyran-2-yl)oxy)-3-hydroxycyclohexyl)-2-hydroxybutanamide
Long Term Storage Condition	2-8°C Refrigerator
Handling instruction	Sample COA

Test	Results
Appearance	white to 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