Description

Quetiapine Impurity 3 CAS NO 99153-65-8 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Quetiapine. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Quetiapine Impurity 3 in drug substance and drug product analysis.
• Analytical Method Development and Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling of Quetiapine.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory filings to demonstrate control strategy.
• Pharmacopoeial Testing: Used for testing against specifications in pharmacopoeias such as USP, EP, or BP where this impurity is monitored.
• Research and Development: Aids in synthetic route optimization and impurity fate and tolerance studies during the API development process.

Basic Information

Product Name	Quetiapine Impurity 3
CAS No.	99153-65-8
Molecular Formula	C21H25N3O2S
Molecular Weight	383.51 g/mol
Synonyms	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 Related Compound C; Quetiapine EP Impurity C; Quetiapine USP Related Compound C; Quetiapine Hydroxyethyl Impurity; N-Desalkyl Quetiapine Metabolite
EINECS	Contact for details

Quality Control

Every batch of Quetiapine Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with industry standards, including ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for purity (HPLC), identification (IR, NMR), and specified impurities. We support compliance with cGMP and relevant pharmacopoeial standards (USP, EP) for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage under inert atmosphere, please contact us for specific recommendations.

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: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w
Assay (on dried basis)	98.0% - 102.0%

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