Description

Quetiapine Hydroxy Impurity Dihydrochloride Salt is a high-purity reference standard and pharmaceutical impurity critical for quality control in drug development and manufacturing. This compound is essential for the accurate identification, quantification, and monitoring of a specific degradation product or synthetic by-product associated with the antipsychotic drug Quetiapine. It is primarily required by pharmaceutical R&D laboratories, analytical testing facilities, and manufacturers engaged in the production of generic or branded Quetiapine formulations to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the calibration of analytical instruments (HPLC, LC-MS) in method development and validation.
• Impurity Profiling & Control: Used for the identification and quantification of the specific hydroxy impurity in active pharmaceutical ingredient (API) batches and finished drug products.
• Stability Studies: Employed as a marker in forced degradation and long-term stability testing to understand the degradation pathways of Quetiapine.
• Regulatory Compliance & Filing: Critical for preparing impurity data packages required for regulatory submissions to agencies like the FDA, EMA, and other global health authorities.
• Quality Assurance/Quality Control (QA/QC): Used in routine batch release testing to ensure impurity levels are within International Council for Harmonisation (ICH) guidelines.
• Research & Development: Facilitates process chemistry research to optimize synthesis routes and minimize the formation of this specific impurity.

Basic Information

Product Name	Quetiapine Hydroxy Impurity Dihydrochloride Salt
CAS No.	329218-14-6
Molecular Formula	C21H27N3O3S • 2HCl
Molecular Weight	490.90 g/mol (for dihydrochloride salt)
Synonyms	11-Hydroxy Quetiapine Dihydrochloride; 11-Hydroxy Quetiapine 2HCl; Quetiapine 11-Hydroxy Impurity Dihydrochloride; 2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol Hydroxy Impurity Dihydrochloride; Quetiapine Related Compound H Dihydrochloride; Quetiapine EP Impurity H Dihydrochloride; Quetiapine USP Impurity H Dihydrochloride
EINECS	Contact for details

Quality Control

Every batch of Quetiapine Hydroxy Impurity Dihydrochloride Salt is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including chromatographic purity, assay, and residual solvent analysis, is provided with each shipment to support your regulatory and quality requirements.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Assay (on dried basis)	97.0% - 102.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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