Description

Asenapine n-Oxide is a key pharmaceutical intermediate and metabolite of the atypical antipsychotic drug asenapine. This compound is of significant importance for research and development in neuropharmacology and analytical chemistry. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in drug metabolism and pharmacokinetic (DMPK) studies, impurity profiling, and reference standard synthesis.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of asenapine and its related substances in drug products and biological matrices.
• Metabolite Identification & DMPK Studies: Critical for studying the metabolic pathways, pharmacokinetics, and bioavailability of asenapine in preclinical and clinical research.
• Impurity Profiling: Serves as a known impurity standard to monitor and control the quality of asenapine active pharmaceutical ingredient (API) during manufacturing, ensuring compliance with ICH guidelines.
• Process Chemistry & Synthesis: Employed as a building block or intermediate in the research-scale synthesis of novel asenapine derivatives or for studying structure-activity relationships (SAR).
• Analytical Method Development: Essential for developing and validating robust HPLC, LC-MS, or GC-MS methods for the detection and quantification of asenapine and its degradants.
• Regulatory Submissions: Provides necessary data and reference materials for regulatory filings (e.g., with FDA, EMA) to demonstrate understanding of drug substance impurities.

Basic Information

Product Name	Asenapine n-Oxide
CAS No.	128949-51-9
Molecular Formula	C₁₇H₁₆ClNO₂
Molecular Weight	301.77 g/mol
Synonyms	Asenapine N-Oxide; Asenapine N-Oxide (Major Metabolite); (3aRS,12bRS)-5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole 2-Oxide; 5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole N-Oxide; Org 5228 N-Oxide; SYCRIT N-Oxide; Asenapine Metabolite M10; Asenapine Related Compound C
EINECS	Contact for details

Quality Control

Our Asenapine n-Oxide is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and consistency. Quality is assured through comprehensive testing via HPLC, NMR, and MS. A detailed Certificate of Analysis (COA) is provided with each batch, confirming identity, purity, and impurity profile. Our quality system supports compliance with cGMP and ICH Q3A/B guidelines for pharmaceutical impurities.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w
Heavy Metals	≤ 20 ppm

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