Description

Quetiapine Impurity P (11-(4-Ethylpiperazin-1-yl)dibenzo[b,f][1,4]thiazepine fumarate) is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a key impurity marker for ensuring the quality, safety, and efficacy of the antipsychotic drug Quetiapine. It is essential for analytical method development, validation, and regulatory compliance in pharmaceutical manufacturing. Quality control laboratories and R&D departments in the global pharmaceutical industry rely on this standard for precise impurity profiling and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Quetiapine Impurity P in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurities in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Quetiapine drug substances and products meet stringent pharmacopoeial specifications (e.g., USP, EP, BP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research on Degradation Pathways: Aids in understanding the chemical stability and degradation mechanisms of Quetiapine fumarate.

Basic Information

Item	Detail
Product Name	Quetiapine Impurity P (11-(4-Ethylpiperazin-1-yl)dibenzo[b,f][1,4]thiazepine fumarate)
CAS No.	1011758-03-4
Molecular Formula	C23H26N4O4S
Molecular Weight	454.54 g/mol
Synonyms	Quetiapine Fumarate Impurity P; 11-(4-Ethyl-1-piperazinyl)dibenzo[b,f][1,4]thiazepine fumarate; Dibenzo[b,f][1,4]thiazepine, 11-(4-ethyl-1-piperazinyl)-, (2E)-2-butenedioate (1:1); Quetiapine Related Compound P; Quetiapine EP Impurity P; Quetiapine USP Impurity P; UNII-9G1K3968QN; Fumaric acid, compound with 11-(4-ethyl-1-piperazinyl)dibenzo[b,f][1,4]thiazepine (1:1)
EINECS	Contact for details

Quality Control

Every batch of Quetiapine Impurity P is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, related substances, residual solvents, and other critical parameters. We support regulatory needs with full traceability and stability data.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Avoid prolonged exposure to high humidity and elevated temperatures.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
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.