Quetiapine D4 Fumarate (Possibility 2)

SZ CAT No:	SZ-Q001D04
CAS No	1331636-50-0
Mol.F.	C21H21D4N3O2S : C4H4O4
Mol.Wt.	387.5 : 116.1
Inv. Status	Custom Synthesis
Rel. CAS No	1031703-35-1 (free base)

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Chemical Name: 2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy-1,1,2,2-d4)ethan-1-ol fumarate

Shipping Temperature: Ambient

HSN Code: 38229010

Country of Origin: India

Smiles: OC(/C=C/C(O)=O)=O.OCCOC([2H])([2H])C([2H])([2H])N1CCN(CC1)C2=NC3=CC=CC=C3SC4=CC=CC=C24

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

Quetiapine D4 Fumarate (Possibility 2) is chemically 2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy-1,1,2,2-d4)ethan-1-ol fumarate. Quetiapine D4 Fumarate (Possibility 2) is supplied with detailed characterization data compliant with regulatory guideline. Quetiapine D4 Fumarate (Possibility 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 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.

Quetiapine D4 Fumarate (Possibility 2)

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