Description

Quetiapine Carboxylate Impurity is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) quetiapine by accurately identifying and quantifying related substances. It is primarily required by analytical laboratories, research institutions, and pharmaceutical companies engaged in method validation, stability studies, and regulatory compliance. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control throughout the drug production lifecycle.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) to identify and quantify the carboxylate-related impurity in Quetiapine Fumarate API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this specific degradation product under various stress conditions.
• Quality Control and Batch Release Testing: Essential for in-house QC laboratories to confirm impurity levels are within International Council for Harmonisation (ICH) and pharmacopeial (USP, EP) specified limits.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to regulatory bodies like the FDA and EMA.
• Research and Development: Used in synthetic chemistry R&D to study impurity formation pathways and to develop purification processes for the API.

Basic Information

Product Name	Quetiapine Carboxylate Impurity
CAS No.	1011758-00-1
Molecular Formula	C23H27N3O4S
Molecular Weight	441.55 g/mol
Synonyms	2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol Carboxylic Acid Derivative; Quetiapine Carboxylic Acid Impurity; Quetiapine Related Compound; 11-(4-{2-[2-(Carboxy)ethoxy]ethyl}piperazin-1-yl)dibenzo[b,f][1,4]thiazepine; DBZ Carboxylate Impurity; Seroquel Carboxylate Impurity; ICI 204,636 Carboxylate Impurity
EINECS	Contact for details

Quality Control

Every batch of Quetiapine Carboxylate Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents. We support compliance with ICH Q3A/B, USP General Chapters, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider desiccant use and storage under inert atmosphere to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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