Quetiapine EP Impurity B (dihydrochloride salt)

Quetiapine EP Impurity B (dihydrochloride salt) is chemically 11-(Piperazin-1-yl)dibenzo[b,f][1,4]thiazepine dihydrochloride (as per EP). It is also known as Quetiapine USP Related Compound B ; N-Desalkyl Quetiapine. Quetiapine EP Impurity B (dihydrochloride salt) is supplied with detailed characterization data compliant with regulatory guideline. Quetiapine EP Impurity B (dihydrochloride salt) 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 Quetiapine.

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 Potential Impurities of Quetiapine Fumarate
Elżbieta U. Stolarczyk,Łukasz Kaczmarek,Kamil Eksanow,Marek Kubiszewski,Magdalena Glice &Andrzej Kutner
Pharmaceutical Development and Technology  Volume 14, 2009 - Issue 1 Pages 29-39
 
An Improved and Single Pot Process for the Production of Quetiapine Hemifumarate Substantially Free from Potential Impurities
Navnath C. Niphade, Anil C. Mali, Bhushan S. Pandit, Kunal M. Jagtap, Sanjay A. Jadhav, Madhukar N. Jachak, and Vijayavitthal T. Mathad
Org. Process Res. Dev. 2009, 13, 4, 792–797
 
Stability indicating fast LC method for determination of quetiapine fumarate related substances in bulk and pharmaceutical formulation
R.Narendra Kumar, *G.Nageswara Rao, P.Y.Naidu
Der Pharmacia Lettre, 2011, 3(3): 457-469

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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.

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• 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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