CERTIFICATE OF ANALYSIS
|
PRODUCT NAME: Amikacin EP Impurity B
|
|
Date of Mfg: Sample COA
|
RETEST DATE: Sample COA
|
| Catalogue Number |
AMK-003
|
|
| Item/Batch Number |
Sample COA
|
| Quantity |
Sample COA
|
| CAS Number |
927821-99-6
|
| Mol. Formula |
C26H50N6O15
|
| Molecular Wt |
686.7 g/mol
|
| IUPAC |
(2S,2'S)-N,N'-((1S,3R,4S,5R,6R)-4-(((2S,3R,4S,5S,6R)-4-Amino-3,5-dihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)-6-(((2R,3R,4S,5S,6R)-6-(amin
|
| Synonyms |
Amikacin Sulfate Impurity B (As per 35.1 EP Monograph); 1,3-Di-HABA Kanamycin A; (2S,2'S)-N,N'-((1S,3R,4S,5R,6R)-4-(((2S,3R,4S,5S,6R)-4-Amino-3,5-dihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)-6-(((2R,3R,4S,5S,6R)-6-(aminomethyl)-3,4,5-trihydroxytetrahydro-2H-pyran-2-yl)oxy)-5-hydroxycyclohexane-1,3-diyl)bis(4-amino-2-hydroxybutanamide);O-3-Amino-3-deoxy-α-D-glucopyranosyl-(1→6)-O-[6-amino-6-deoxy-α-D-glucopyranosyl-(1→4)]-N1,N3-bis[(2S)-4-amino-2-hydroxy-1-oxobutyl]-2-deoxy-D-streptamine
|
| 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
|