Description

Quetiapine Impurity (N,n-Bis[(2-Phenylthio)Phenyl]-1,4-Piperazinedicarboxamide) is a high-purity reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of the active pharmaceutical ingredient (API) quetiapine, an atypical antipsychotic. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling to ensure drug safety and efficacy.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity during the manufacturing and quality control of Quetiapine fumarate API.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to ensure accurate detection and quantification limits.
• Stability Studies and Forced Degradation: Employed in stability-indicating assays to understand the degradation pathways of Quetiapine and establish appropriate shelf-life and storage conditions.
• Regulatory Submissions and Compliance: Essential for generating data required for regulatory filings (e.g., FDA, EMA, ICH guidelines) to demonstrate control over impurities as per ICH Q3A(R2) and Q3B(R2).
• Pharmacopoeial Testing: Used as a reference standard for testing against specifications in pharmacopoeias such as USP, EP, or BP.
• Research and Development: Utilized in preclinical and clinical research to study the formation, toxicity, and behavior of this impurity.
• Quality Assurance/Quality Control (QA/QC): A key component in the routine batch release testing of Quetiapine to ensure it meets stringent purity specifications.
• Calibration of Analytical Equipment: Acts as a calibrant to ensure the accuracy and precision of analytical instruments used in pharmaceutical analysis.

Basic Information

Item	Detail
Product Name	Quetiapine Impurity (N,n-Bis[(2-Phenylthio)Phenyl]-1,4-Piperazinedicarboxamide)
CAS No.	1126432-68-5
Molecular Formula	C36H30N4O2S2
Molecular Weight	614.78 g/mol
Synonyms	N,N-Bis[2-(Phenylthio)phenyl]-1,4-piperazinedicarboxamide; 1,4-Piperazinedicarboxamide, N,N-bis[2-(phenylthio)phenyl]-; Quetiapine Related Compound; Quetiapine Fumarate Impurity; Bis(2-(phenylthio)phenyl)carbamoylpiperazine-1-carboxamide; Quetiapine Process Impurity; Seroquel Impurity
EINECS	Contact for details

Quality Control

Every batch of our Quetiapine Impurity is manufactured and analyzed under strict quality systems. The product undergoes rigorous testing including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH guidelines and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches 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)	≤ 1.0% w/w

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