N-Nitroso Enzalutamide Impurity 2

N-Nitroso Enzalutamide Impurity 2 is chemically Methyl 2-((3-fluoro-4-(methylcarbamoyl)phenyl)(nitroso)amino)-2-methylpropanoate. N-Nitroso Enzalutamide Impurity 2 is supplied with detailed characterization data compliant with regulatory guideline. N-Nitroso Enzalutamide Impurity 2 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 Enzalutamide.

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.

Structural elucidation of the impurities in Enzalutamide bulk drug and the development, validation of corresponding HPLC method
Xingling Mab , Wentao Zhoua , Qiaogen Zoua,*, Pingkai Ouyang
Journal of Pharmaceutical and Biomedical Analysis Volume 131, 30 November 2016, Pages 436-443
 
Crystal Forms of Enzalutamide and a Crystal Engineering Route to Drug Purification
Lucia Maini, Dario Braga, Francesco Farinella, Elisa Melotto, Massimo Verzini, Roberto Brescello, Ivan Michieletto, and Ilaria Munari
Cryst. Growth Des. 2018, 18, 7, 3774–3780
 
Quantitative Study of Impurities in Enzalutamide and Identification, Isolation, Characterization of Its Four Degradation Products Using HPLC, Semi-preparative LC, LC/ESI–MS and NMR Analyses
Ainan Zhou1,2 · Lejun Ruan1  · Gengli Duan2  · Jianqi Li
Chromatographia volume 81, pages1519–1531(2018)
 
Validation of a method for quantifying enzalutamide and its major metabolites in human plasma by LC–MS/MS
Daniel Bennett, Jacqueline A Gibbons, Roelof Mol, Yoshiaki Ohtsu & Clark Williard
Bioanalysis (2014) 6(6), 737–744

• 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.

Reach to Us:

• All communication will be addressed to standards@synzeal.com
• SynZeal emphasize on formal communication which is required for smooth processing of the purchase order. It helps multiple people to remain informed about all details.
• For specific purpose, there are below e-mail address to be used.
  • For New products # standards@synzeal.com
  • Order confirmation # order@synzeal.com
  • Open Order Status # projects@synzeal.com
  • Data related Query # support@synzeal.com
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  • Logistic Documents # exports@synzeal.com (For export customer only)
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• SynZeal is committed for promptly responding all communication however if sometime urgent comes us you can use our WhatsApp customer care channel (+91 70690 37751) to reach to customer support team. You can also request call back on WhatsApp and our customer support team will reach to you in defined timeframe.