CERTIFICATE OF ANALYSIS

PRODUCT NAME: Desacetyl Apremilast
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number APL-008
Item/Batch Number Sample COA
Quantity Sample COA
CAS Number 635705-72-5
Mol. Formula C20H22N2O6S
Molecular Wt 418.46 g/mol
IUPAC (S)-4-Amino-2-(1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)isoindoline-1,3-dione
Synonyms 4-Amino-2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-1H-isoindole-1,3(2H)-dione; (S)-4-Amino-2-(1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)isoindoline-1,3-dione; N-Deacetyl Apremilast; ((S)-4amino-2(1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)isoindoline-1,3-dione) (as per IP); Apremilast Impurity B (IP)
Long Term Storage Condition 2-8°C, Refrigerator, under inert atmosphere
Handling instruction Sample COA
Test Results
Appearance Off-White to Yellow 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