Description

n-Demethylolanzapine-D8 is a deuterium-labeled internal standard of a key olanzapine metabolite, essential for precise quantitative analysis in bioanalytical studies. This high-purity reference material is critical for ensuring accuracy and reliability in pharmacokinetic and metabolic research, where method validation and regulatory compliance are paramount. It is primarily used by pharmaceutical R&D laboratories, contract research organizations (CROs), and forensic toxicology labs engaged in advanced LC-MS/MS and GC-MS applications.

Application

• LC-MS/MS and GC-MS Internal Standard: For the accurate quantification of olanzapine and its metabolites in biological matrices (plasma, serum, urine).
• Pharmacokinetic and Bioequivalence Studies: Enables precise tracking of drug metabolism and exposure in clinical trials.
• Forensic and Clinical Toxicology: Supports reliable identification and measurement of olanzapine in cases of overdose or therapeutic drug monitoring.
• Drug Metabolism and Disposition (DMPK) Research: Used to elucidate metabolic pathways and study drug-drug interactions.
• Method Development and Validation: Serves as a critical component for developing robust, GLP-compliant analytical methods.
• Quality Control in Pharmaceutical Manufacturing: Can be utilized in impurity profiling and stability testing of olanzapine-based drug products.

Basic Information

Product Name	n-Demethylolanzapine-D8
CAS No.	786686-82-6
Molecular Formula	C₁₆H₁₂D₈N₄S
Molecular Weight	308.48 g/mol
Synonyms	2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine-d8; Olanzapine Metabolite-d8; 2-Hydroxymethyl Olanzapine-d8; Desmethylolanzapine-d8; LY 170052 Metabolite-d8; 10H-Thieno[2,3-b][1,5]benzodiazepine-d8 derivative; Deuterated n-Demethylolanzapine
EINECS	Contact for details

Quality Control

Every batch of n-Demethylolanzapine-D8 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and isotopic enrichment. Our quality commitment includes comprehensive characterization by NMR, HPLC, and mass spectrometry. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming specifications for chemical purity, isotopic purity (D8), and residual solvents in compliance with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥98.0%
Isotopic Purity (D8)	≥98.0 atom % D
Chemical Purity (by NMR)	≥95.0%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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