Description

n-Desmethyl Asenapine-D4 Hydrochloride is a high-purity, isotopically labeled internal standard critical for advanced analytical applications. This deuterated compound is essential for ensuring the accuracy and reliability of quantitative bioanalytical methods, particularly in pharmacokinetic and metabolic studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in method development and validation for the antipsychotic drug asenapine.

Application

• Quantitative Bioanalysis: Serves as a stable isotope-labeled internal standard for the precise quantification of asenapine and its metabolites in biological matrices (e.g., plasma, serum) using LC-MS/MS and GC-MS.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in clinical and preclinical research.
• Metabolite Identification & Profiling: Aids in the structural elucidation and quantification of desmethyl asenapine metabolites, facilitating a deeper understanding of drug metabolism pathways.
• Method Development & Validation: Used as a critical reference material to develop, optimize, and validate robust, GLP-compliant analytical methods for regulatory submissions.
• Doping Control & Forensic Analysis: Applicable in specialized testing for the detection and confirmation of asenapine in forensic and anti-doping contexts.
• Quality Control in Pharmaceutical Manufacturing: Supports impurity profiling and stability testing of asenapine active pharmaceutical ingredients (APIs) and finished drug products.

Basic Information

Product Name	n-Desmethyl Asenapine-D4 Hydrochloride
CAS No.	1246820-54-1
Molecular Formula	C16H10D4Cl2N2O • HCl
Molecular Weight	Contact for details
Synonyms	Desmethylasenapine-d4 HCl; 5-Chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole-d4 Hydrochloride; Asenapine N-Desmethyl-D4 Hydrochloride; Asenapine Metabolite D4 Hydrochloride; 1-Desmethyl Asenapine-D4 HCl; Deuterated Desmethyl Asenapine HCl; Internal Standard for Asenapine-d4
EINECS	Contact for details

Quality Control

Our n-Desmethyl Asenapine-D4 Hydrochloride is manufactured under strict quality control protocols to ensure the high chemical purity and isotopic enrichment required for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing parameters such as assay (HPLC), isotopic purity (NMR/MS), chemical purity, and residual solvent content. We support compliance with cGMP and ISO 9001 standards for research and diagnostic use.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 98 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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