CERTIFICATE OF ANALYSIS

PRODUCT NAME: Pregabalin EP Impurity D
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number PRG-011
Item/Batch Number Sample COA
Quantity Sample COA
CAS Number 4118-51-8
Mol. Formula C11 H14 O3
Molecular Wt 194.23 g/mol
IUPAC 1-Methylethyl (2RS)-2-hydroxy-2-phenylacetate
Synonyms Isopropyl DL-Mandelate; (+/-)-Mandelic acid isopropyl ester; Isopropyl 2-hydroxy-2-phenylacetate
Long Term Storage Condition 2-8 °C for long term storage
Handling instruction Sample COA
Test Results
Appearance White to Off-White Low-Melting 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 Chloroform (Slightly), Methanol (Sparingly)
Purity 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