CERTIFICATE OF ANALYSIS

PRODUCT NAME: Apremilast EP Impurity H
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number APL-009
Item/Batch Number Sample COA
Quantity Sample COA
CAS Number 253168-94-4
Mol. Formula C12H19NO4S
Molecular Wt 273.4 g/mol
IUPAC 1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethan-1-amine
Synonyms 3-Ethoxy-4-methoxy-α-[(methylsulfonyl)methyl]benzenemethanamine; 2-(3-Ethoxy-4-methoxyphenyl)-1-(methylsulfonyl)eth-2-ylamine; Apremilast amine; 1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethan-1-amine (As per USP Commenting Opening 51(2))
Long Term Storage Condition 2-8°C Refrigerator
Handling instruction Sample COA
Test Results
Appearance hite to off-white crystalline powder or 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