CERTIFICATE OF ANALYSIS

PRODUCT NAME: Amikacin EP Impurity I
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number AMK-007
Lot Number Sample COA
Batch Quantity Sample COA
CAS Number 40371-51-5
Mol. Formula C4H9NO3
Molecular Wt 119.1 g/mol
Long Term Storage Condition 2-8°C Hygroscopic, Refrigerator, under inert atmosphere Handling instruction Sample COA
IUPAC (2S)-4-amino-2-hydroxybutanoic acid
Chemical Name Amikacin EP Impurity I
Synonyms Amikacin Sulfate Impurity I (As per 35.1 EP Monograph); (S)-(-)-4-Amino-2-hydroxybutyric Acid; (S)-4-Amino-2-hydroxybutanoic Acid; (S)-4-Amino-2-hydroxybutyric Acid; 4-Amino-(2S)-hydroxybutyric Acid;L-γ-Amino-α-hydroxybutyric Acid; L-(-)-γ-Amino-α-hydroxybutyric Acid; L-4-Amino-2-hydroxybutyric Acid
Test Results
Appearance Off-White Solid
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