CERTIFICATE OF ANALYSIS

PRODUCT NAME: Pregabalin Impurity I
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number PRG-018
Item/Batch Number Sample COA
Quantity Sample COA
CAS Number NA
Mol. Formula C23H40N2O4
Molecular Wt 408.58
IUPAC (R)-3-(bis((S)-4-isobutyl-2-oxopyrrolidin-1-yl)methyl)-4-methylpentanoic acid
Synonyms Pregabalin Impurity 56
Long Term Storage Condition 2-8°C Refrigerator
Handling instruction Sample COA
Test Results
Appearance
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 95%
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