Description

Quetiapine 2-Hydroxy Impurity is a key pharmacopoeial impurity and reference standard used in the analytical profiling of the antipsychotic drug Quetiapine. Its precise characterization is critical for ensuring drug safety, efficacy, and regulatory compliance in pharmaceutical manufacturing. This high-purity compound is essential for quality control laboratories, research institutions, and API manufacturers focused on method development, validation, and impurity identification.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the quantitative and qualitative analysis of Quetiapine fumarate and related drug products.
• Impurity Profiling & Method Development: Used in HPLC, UPLC, and LC-MS methods to identify, quantify, and monitor the 2-hydroxy impurity during stability studies and release testing.
• Active Pharmaceutical Ingredient (API) Quality Control: A critical component in the impurity control strategy for Quetiapine fumarate manufacturing, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submission & Compliance: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing authenticated impurity data for drug master files.
• Research & Development: Utilized in metabolic studies, degradation pathway investigation, and the synthesis of related impurity markers.

Basic Information

Product Name	Quetiapine 2-Hydroxy Impurity
CAS No.	1241800-24-7
Molecular Formula	C21H25N3O2S
Molecular Weight	383.51 g/mol
Synonyms	2-Hydroxy Quetiapine; Quetiapine 2-Hydroxy Analog; Quetiapine Related Compound; 2-Hydroxy-11-(4-(2-hydroxyethoxy)piperazin-1-yl)dibenzo[b,f][1,4]thiazepine; 11-[4-[2-Hydroxyethoxy]piperazin-1-yl]dibenzo[b,f][1,4]thiazepin-2-ol; Quetiapine Impurity (2-Hydroxy); Quetiapine EP Impurity; Quetiapine USP Impurity
EINECS	Contact for details

Quality Control

Our Quetiapine 2-Hydroxy Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with pharmacopoeial (USP, EP) and ICH guidelines.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 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.