Description

Labeled D8 Desmethyl Clozapine Hydrochloride is a high-purity, deuterium-labeled internal standard critical for advanced analytical quantification in pharmaceutical research and development. This stable isotope-labeled compound is essential for ensuring the accuracy, precision, and reliability of mass spectrometry-based bioanalytical methods. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and academic laboratories engaged in pharmacokinetic studies, metabolite identification, and drug metabolism and pharmacokinetics (DMPK) research for clozapine and related compounds.

Application

• Quantitative Bioanalysis: Serves as an internal standard for the precise LC-MS/MS quantification of desmethyl clozapine and its metabolites in complex biological matrices such as plasma, serum, and tissue homogenates.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug concentration over time to establish exposure-response relationships for clozapine therapies.
• Metabolite Profiling and Identification: Aids in the detection and structural elucidation of novel metabolites in drug metabolism studies.
• Method Development and Validation: Provides a stable, non-interfering reference for developing and validating robust, GLP-compliant analytical methods.
• Therapeutic Drug Monitoring (TDM) Research: Supports research into optimized dosing regimens by allowing precise measurement of active drug moiety levels.
• Impurity and Degradant Analysis: Used as a reference standard in stability-indicating methods to quantify process-related impurities or degradation products.

Basic Information

Product Name	Labeled D8 Desmethyl Clozapine Hydrochloride
CAS No.	1189888-77-4
Molecular Formula	C17H10D8ClN4•HCl
Molecular Weight	352.29 g/mol (for monoisotopic)
Synonyms	8-Chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine-d8 Hydrochloride; Norclozapine-d8 Hydrochloride; Desmethylclozapine-d8 HCl; 1-Methyl-4-piperazine-d8, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine Hydrochloride; N-Desmethylclozapine-d8 Hydrochloride; Clozapine Metabolite N-Desmethylclozapine-d8 HCl; Deuterated Desmethyl Clozapine HCl
EINECS	Contact for details

Quality Control

Every batch of Labeled D8 Desmethyl Clozapine Hydrochloride is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of isotopic purity, chemical purity, and stability. Our quality commitment includes comprehensive characterization by NMR, HPLC, and mass spectrometry. A detailed Certificate of Analysis (COA) providing batch-specific data for identity, purity (HPLC), isotopic enrichment, and related substances is supplied with each product to support your regulatory and research requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C in a dry, cool place. This product is hygroscopic (moisture-sensitive) and light-sensitive. For long-term storage, consider desiccation and storage under inert atmosphere to maintain stability and isotopic integrity.

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 (D-enrichment)	≥ 98 atom % D
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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