Apremilast Impurity 32

Apremilast Impurity 32 is chemically 1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethan-1-one. Apremilast Impurity 32 is supplied with detailed characterization data compliant with regulatory guideline. Apremilast Impurity 32 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.

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)

• We need to receive valid purchase order with Bill to & Ship to address.
• The quotation ID needs to be mentioned in the purchase order.
• You will receive order confirmation prior to dispatch which need to be verified for any error in product, pack size, prices.

Delivery time:

• In Stock product will dispatch in 24 h after receipt of purchase order. It usually take 2-3 days to receive products in India and 5-6 working days for export customer depending on destination.
• The custom synthesis products would be dispatched as per quoted timeline.

Shipping:

• There will be 100 USD towards logistic charges per shipment if we used our FedEx. There will not be any charge if we use your FedEx/DHL Account. Depending on part shipment logistic charges will be added.
• For countries dispatch by courier is not allowed where product would be dispatched in cargo mode as per agreed Inco term.

Additional Charges:

• Controlled substance charges need to follow as per quotation. The specific inputs are required for controlled substance because regulatory status will differ based on destination.
• Cold Shipment Charges needs to be considered as per quotation.
• For ice pack there are no additional charges.

Technical Queries:

• All technical queries need to raise within 15 days of product receipt. Thereafter it will be our resolved at our discretion.

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• All communication will be addressed to standards@synzeal.com
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