Description

Quetiapine Fumarate CAS NO 111974-72-2 is the fumarate salt form of the atypical antipsychotic quetiapine, a dibenzothiazepine derivative. It is a critical active pharmaceutical ingredient (API) essential for the formulation of effective neuropsychiatric medications. This compound is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of treatments for mental health disorders.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of antipsychotic tablets and extended-release formulations.
• Neuropsychiatric Treatment: Formulation of medications indicated for schizophrenia, bipolar disorder (mania and depression), and major depressive disorder (as adjunctive therapy).
• Clinical Research: Serves as a reference standard and key material in pharmacokinetic, pharmacodynamic, and bioequivalence studies.
• Generic Drug Production: Essential for manufacturers producing generic versions of branded quetiapine medications.
• Dosage Form Development: Used in R&D for developing novel drug delivery systems, such as controlled-release or orally disintegrating tablets.
• Analytical Testing: Employed as a high-purity standard in quality control laboratories for HPLC, UV, and other analytical methods.

Basic Information

Product Name	Quetiapine Fumarate
CAS No.	111974-72-2
Molecular Formula	C46H54N6O4S2•C4H4O4
Molecular Weight	883.12 g/mol
Synonyms	Quetiapine Hemifumarate; 2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol Fumarate (1:1); ICI 204,636; Seroquel (Brand Name); Quetiapine (Base); Bietiapine Fumarate; Quetiapine Fumarate Salt
EINECS	Contact for details

Quality Control

Our Quetiapine Fumarate is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards such as USP and EP. Every batch undergoes comprehensive analytical testing including identification, assay, impurity profiling, and residual solvent analysis. A Certificate of Analysis (COA) documenting all test results is provided to ensure full traceability and quality assurance for our B2B clients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption and degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.15% Total impurities: ≤ 0.5%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.