Category
Quetiapine
CAS Number
329216-67-3
Alternate CAS Number
329218-14-6 (2 HCl Salt)
Molecular Formula
C19H21N3OS
Molecular Weight
339.46 g/mol
Synonym

2-[4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl]ethanol; Quetiapine Alcohol Impurity; Quetiapine Ethanol Impurity; Quetiapine Hydroxy Impurity; 4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazineethanol; 

Keywords
Fine Chemicals
Pharmaceutical Standards
Intermediates
Impurities
Metabolites.
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Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Quetiapine EP Impurity I is used as a reference standard for the detection and quantification of specified impurities in quetiapine drug substances and dosage forms. It supports analytical method development, validation, and stability studies to ensure compliance with European Pharmacopoeia quality standards.