CERTIFICATE OF ANALYSIS

PRODUCT NAME: Amikacin IHRS
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number AMK-013
Item/Batch Number Sample COA
Quantity Sample COA
CAS Number 37517-28-5
Alternate CAS Number 39831-55-5(Amikacin sulphate - API (Disulphate Sal
Mol. Formula C22H43N5O13
Molecular Wt 585.6 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,4S,5S,6R)
Synonyms Amikacin - API (IP); 6-O-(3-Amino-3-deoxy-α-D-glucopyranosyl)-4-O-(6-amino-6-deoxy-α-D- glucopyranosyl)-1-N-[(2S)-4-amino-2-hydroxybutanoyl]-2-deoxy-D-streptamine; Amikacillin; Amikozit; Amukin; Antibiotic BB-K 8; Arikace; Lukadin; Potentox;(S)-O-3-Amino-3-deoxy-α-D-glucopyranosyl-(1→6)-O-[6-amino-6-deoxy-α-D-glucopyranosyl-(1→4)]-N1-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-D-streptamine; 1-N-[L-(-)-γ-Amino-α-hydroxybutyryl]kanamycin A; Amicacin; BAY 41-6551; BAY 416651; BB-K 8; (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,4S,5S,6R)-6-(aminomethyl)-3,4,5-trihydroxytetrahydro-2H-pyran-2-yl)oxy)-3-hydroxycyclohexyl)-2-hydroxybutanamide (USP)
Long Term Storage Condition 2-8°C Hygroscopic, Refrigerator, under inert atmosphere
Handling instruction Sample COA
Test Results
Appearance White Solid
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