Description

Asenapine-13C,D3 is a stable isotope-labeled analog of the atypical antipsychotic drug asenapine, specifically designed for use as an internal standard in quantitative bioanalytical methods. This high-purity reference material is essential for ensuring the accuracy, precision, and regulatory compliance of pharmacokinetic, metabolism, and bioequivalence studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities specializing in mass spectrometry.

Application

• Liquid Chromatography-Mass Spectrometry (LC-MS/MS) Internal Standard: Critical for the precise quantification of asenapine in complex biological matrices such as plasma, serum, and tissue homogenates.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used to track the absorption, distribution, metabolism, and excretion (ADME) profile of asenapine in preclinical and clinical research.
• Bioanalytical Method Development and Validation: Serves as a key component in developing robust, sensitive, and selective analytical assays compliant with FDA, EMA, and ICH guidelines.
• Therapeutic Drug Monitoring (TDM): Enables accurate measurement of asenapine concentrations in patient samples to optimize dosing and ensure therapeutic efficacy.
• Impurity Profiling and Degradation Studies: Aids in the identification and quantification of potential degradants or metabolites in drug substance and product stability testing.
• Forensic and Clinical Toxicology: Provides a reliable reference for confirming the presence and concentration of asenapine in forensic investigations or overdose cases.

Basic Information

Product Name	Asenapine-13C,D3
CAS No.	1217729-73-1
Molecular Formula	C17H1313C2H3Cl2NOS
Molecular Weight	~ 288.22 g/mol (labeled)
Synonyms	(3aRS,12bRS)-5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole-13C,D3; (3aR,12bR)-rel-5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole-13C,D3; Asenapine-13C,D3 Maleate (salt form); Asenapine-d3-13C; Asenapine Internal Standard-13C,D3; SYCRIT-13C,D3; SAPHRIS-13C,D3 (labeled analog)
EINECS	Contact for details

Quality Control

Every batch of Asenapine-13C,D3 is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity, supported by comprehensive analytical data from techniques including NMR (1H, 13C), High-Resolution Mass Spectrometry (HRMS), and HPLC. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific purity, isotopic enrichment, and confirming the absence of unlabeled analyte. Our quality commitment ensures compliance with the standards expected for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This compound is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccation. Keep the container sealed under an inert atmosphere to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 99 atom % 13C; ≥ 98 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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