Apremilast Desphthalyl Amine (N-Acetyl-L-leucine) (USP)

Identification and characterization of process-related substances and degradation products in apremilast: process optimization and degradation pathway elucidation
Yuting Lu, Xiaoyue Shen, Taijun Hang, Min Song
J Pharm Biomed Anal. 2017 Jul 15;141:70-78
 
Discovery of (S)-N-{2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methanesulfonylethyl]-1,3-dioxo2,3-dihydro-1H-isoindol-4-yl}acetamide (Apremilast), a Potent and Orally Active Phosphodiesterase 4 and Tumor Necrosis Factor-r Inhibitor
Hon-Wah Man, Peter Schafer, Lu Min Wong, Rebecca T. Patterson, Laura G. Corral, Heather Raymon, Kate Blease, Jim Leisten, Michael A. Shirley, Yang Tang, Darius M. Babusis, Roger Chen, Dave Stirling, and George W. Muller
J. Med. Chem. 2009, 52, 1522–1524
 
Identification, characterization and HPLC quantification for impurities of Apremilast
Kaihe Xionga , Xingling Mab , Na Caob ,Lei Liub ,Lili Suna , Qiaogen Zoub , Ping Wei
Analytical Methods 8(8)
 
Design of experiment avenue for development and validation of RP-HPLC-PDA method for determination of apremilast in bulk and in in-house tablet formulation
Suraj R. Chaudhari* and Atul A. Shirkhedkar
Journal of Analytical Science and Technology volume 10, Article number: 10 (2019)

Apremilast Desphthalyl Amine (N-Acetyl-L-leucine) (USP) is chemically (S)-1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethan-1-amine acetyl-L-leucinate (as per USP). Apremilast Desphthalyl Amine (N-Acetyl-L-leucine) (USP) is supplied with detailed characterization data compliant with regulatory guideline. Apremilast Desphthalyl Amine (N-Acetyl-L-leucine) (USP) can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Apremilast.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.