Description

Quetiapine Impurity Sp is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) quetiapine fumarate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Quetiapine Fumarate API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or other chromatographic methods for quality control laboratories.
• Stability Studies: Employed to monitor the formation and levels of this impurity during forced degradation and long-term stability testing of pharmaceutical products.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Used in R&D settings to study the degradation pathways and chemical behavior of Quetiapine.
• Quality Control Testing: Acts as a system suitability standard and for routine batch release testing in QC laboratories to ensure API and drug product specifications are met.

Basic Information

Product Name	Quetiapine Impurity Sp
CAS No.	14258-43-6
Molecular Formula	C21H25N3O2S
Molecular Weight	383.51 g/mol
Synonyms	Quetiapine Related Compound Sp; Quetiapine EP Impurity Sp; Quetiapine USP Impurity Sp; 2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol; 11-Piperazinyldibenzo[b,f][1,4]thiazepine-2-ethoxyethanol; Quetiapine Alcohol Impurity; Quetiapine Hydroxyethyl Impurity; Quetiapine N-Oxide Impurity Precursor
EINECS	Contact for details

Quality Control

Our Quetiapine Impurity Sp is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, spectroscopic identification (IR, NMR, MS), and residual solvent analysis to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle and store under inert atmosphere if prolonged storage is required.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 0.5%
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.