Description

11-Hydroxyasenapine is a significant metabolite of the atypical antipsychotic drug asenapine. This compound is of critical importance in pharmaceutical research and development, serving as a key reference standard for analytical and metabolic studies. It is essential for scientists and quality control professionals in the pharmaceutical industry who require high-purity materials for method development, bioanalytical testing, and pharmacokinetic research.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the quantification and identification of asenapine and its metabolites in biological matrices.
• Metabolite Profiling & Pharmacokinetics: Critical for studying the metabolic pathways, clearance rates, and exposure levels of asenapine in preclinical and clinical research.
• Bioanalytical Method Development: Used to develop and validate sensitive HPLC, LC-MS, or GC-MS methods for therapeutic drug monitoring (TDM) and toxicology studies.
• Impurity Characterization: Employed in the identification and control of process-related impurities and degradation products in asenapine active pharmaceutical ingredient (API) manufacturing.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., for FDA, EMA) by providing definitive characterization data for a major human metabolite.

Basic Information

Product Name	11-Hydroxyasenapine
CAS No.	1262639-38-2
Molecular Formula	C17H16ClNO
Molecular Weight	285.77 g/mol
Synonyms	(3aR,12bR)-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrol-1-ol; 11-Hydroxy Asenapine; 11-OH-Asenapine; Asenapine Metabolite M4; Asenapine Hydroxy Metabolite
EINECS	Contact for details

Quality Control

Our 11-Hydroxyasenapine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide full traceability and Certificates of Analysis (COA) that detail all test results against stringent in-house specifications, ensuring material suitability for demanding research applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%
Total Impurities	≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH guidelines

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