Description

Quetiapine Impurity Iii (N,n-Bis[2-(Phenylthio)Phenyl]Urea) 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 involved in the development, production, and quality assurance of Quetiapine formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Quetiapine fumarate API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or GC methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to monitor impurity levels and ensure every batch of Quetiapine meets stringent pharmacopeial specifications (USP, EP).
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to support drug approval processes.
• Research & Development: Used in pharmaceutical R&D to understand degradation pathways and synthesis by-products during the development of Quetiapine and its generic versions.

Basic Information

Product Name	Quetiapine Impurity Iii (N,n-Bis[2-(Phenylthio)Phenyl]Urea)
CAS No.	102893-57-2
Molecular Formula	C31H24N2OS2
Molecular Weight	504.66 g/mol
Synonyms	Quetiapine Related Compound C; Quetiapine Impurity C; 1,1'-(Thiocarbonyl)bis[2-(phenylthio)benzene]; N,N-Bis[2-(Phenylthio)phenyl]urea; Urea, N,N-bis[2-(phenylthio)phenyl]-; Bis(2-(phenylthio)phenyl)urea; Quetiapine Fumarate Impurity III
EINECS	Contact for details

Quality Control

Our Quetiapine Impurity Iii is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for use as a pharmaceutical reference material. Certificates of Analysis (COA) with detailed chromatographic data, including lot-specific purity and traceability information, are provided and can be tailored to support regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.