Description

n-Desmethyl Asenapine Hydrochloride is a key pharmaceutical intermediate and reference standard in the synthesis and analytical profiling of the antipsychotic drug asenapine. This compound is critical for quality control, method development, and regulatory compliance in active pharmaceutical ingredient (API) manufacturing. It is primarily required by pharmaceutical R&D laboratories, analytical service providers, and manufacturers of high-purity fine chemicals for the production and validation of neuropsychiatric therapeutics.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quantitative and qualitative analysis of asenapine active pharmaceutical ingredient (API) by HPLC, LC-MS, and other chromatographic methods.
• Metabolite Studies: Serves as a crucial metabolite reference compound in pharmacokinetic, pharmacodynamic, and drug metabolism studies during clinical research and development.
• Process Chemistry & Impurity Control: Employed in the development and optimization of synthetic routes for asenapine, helping to identify, monitor, and control process-related impurities to meet ICH guidelines.
• Regulatory Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed characterization and specification of potential impurities and degradation products.
• Analytical Method Validation: Acts as a system suitability and specificity test compound in the validation of stability-indicating assay methods for asenapine formulations.
• Custom Synthesis & Derivative Research: Used as a building block for the research-scale synthesis of novel asenapine analogs and derivatives in medicinal chemistry programs.

Basic Information

Product Name	n-Desmethyl Asenapine Hydrochloride
CAS No.	1170701-78-6
Molecular Formula	C₁₇H₁₆ClNO
Molecular Weight	285.77 g/mol
Synonyms	Desmethyl Asenapine HCl; 5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole Hydrochloride; Asenapine N-Desmethyl Impurity Hydrochloride; Asenapine Metabolite Hydrochloride; 1-[(3aR,12bR)-5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenzo[2,3:6,7]oxepino[4,5-c]pyrrol-2-yl]methanone Hydrochloride; Org 5228 Desmethyl Impurity; SYCRIT Desmethyl Impurity HCl
EINECS	Contact for details

Quality Control

Our n-Desmethyl Asenapine Hydrochloride is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical impurity standards and research. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%
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.