CERTIFICATE OF ANALYSIS

PRODUCT NAME: Amikacin EP Impurity I
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number AMK-007
Item/Batch Number Sample COA
Quantity Sample COA
CAS Number 40371-51-5
Mol. Formula C4H9NO3
Molecular Wt 119.1 g/mol
IUPAC (2S)-4-amino-2-hydroxybutanoic acid
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
Long Term Storage Condition 2-8°C Hygroscopic, Refrigerator, under inert atmosphere
Handling instruction Sample COA
Test Results
Appearance Off-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