Active Pharmaceutical Ingredient

Quetiapine

Also known as: Seroquel; Quetiapin; Quetiapine Fumarate

CAS: 111974-69-7 Antipsychotic IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Quetiapine API — Mediocon Inc
Quetiapine — Pharmaceutical Grade API

Product Overview

CAS No: 111974-69-7  |  MF: C₂₁H₂₅N₃O₂S  |  MW: 383.51 g/mol

Quetiapine is a pharmaceutical-grade active ingredient classified as an Atypical Antipsychotic Dibenzothiazepine. Mediocon Inc supplies high-purity Quetiapine API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Quetiapine is an atypical antipsychotic used in the treatment of schizophrenia, bipolar disorder, and as adjunctive therapy for major depressive disorder. It acts by blocking dopamine D2, serotonin 5-HT2A, and multiple other receptors, providing a broad spectrum of antipsychotic and mood-stabilizing effects.

Key Features

  • High-purity pharmaceutical grade API
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Schizophrenia (acute and maintenance treatment)
  • Bipolar disorder (manic and depressive episodes)
  • Adjunctive therapy for major depressive disorder
  • Extended-release formulations for once-daily dosing

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameQuetiapine
Also Known AsSeroquel; Quetiapin; Quetiapine Fumarate
CAS Number111974-69-7
Molecular FormulaC₂₁H₂₅N₃O₂S
Molecular Weight383.51 g/mol
CategoryAtypical Antipsychotic — Dibenzothiazepine
AppearanceWhite to off-white crystalline powder
SolubilityFreely soluble in water as fumarate salt; slightly soluble in free base form
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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