Description

7-Hydroxy Quetiapine Acetate is a key pharmaceutical intermediate and metabolite of the antipsychotic drug Quetiapine. This compound is of significant importance for analytical research, method development, and quality control in pharmaceutical manufacturing. It is primarily required by pharmaceutical R&D laboratories, analytical service providers, and manufacturers of active pharmaceutical ingredients (APIs) for use as a reference standard and in impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantification and identification of 7-Hydroxy Quetiapine and related substances in drug substance and finished product analysis.
• Metabolite Studies: Essential for in-vitro and in-vivo metabolism studies to understand the pharmacokinetic profile of Quetiapine.
• Impurity Profiling: Critical for monitoring and controlling the level of this specific degradation product or metabolite during the stability testing and shelf-life determination of Quetiapine formulations.
• Method Development & Validation: Serves as a critical analyte for developing and validating robust analytical methods, including HPLC, UPLC, and LC-MS/MS, in compliance with ICH guidelines.
• Bioanalytical Research: Employed in the calibration of assays for determining Quetiapine and its metabolites in biological matrices such as plasma and serum.
• Regulatory Submissions: Used to generate data for regulatory filings (e.g., FDA, EMA) to demonstrate understanding and control of product-related impurities.

Basic Information

Product Name	7-Hydroxy Quetiapine Acetate
CAS No.	329217-62-1
Molecular Formula	C23H27N3O3S
Molecular Weight	425.55 g/mol
Synonyms	7-Hydroxyquetiapine Acetate; 2-[2-(4-{2-Hydroxyethoxy}phenyl)-1-piperazinyl]ethoxy]-7-hydroxy-4H-3,1-benzothiazin-4-one Acetate; Quetiapine 7-Hydroxy Metabolite Acetate; 7-OH-Quetiapine Acetate; 7-Hydroxy Quetiapine Acetate Salt; 7-Hydroxy Quetiapine Acetate Salt; Norquetiapine Acetate (related); Quetiapine Related Compound H Acetate
EINECS	Contact for details

Quality Control

Our 7-Hydroxy Quetiapine Acetate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity determination by HPLC, and control of specific impurities. A detailed Certificate of Analysis (COA) is provided with each shipment, ensuring traceability and compliance with relevant standards for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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