Description

Olanzapine-D8 is a deuterated internal standard of the atypical antipsychotic drug Olanzapine, specifically designed for analytical and research applications. Its primary value lies in providing superior accuracy and reliability in quantitative mass spectrometry (MS) and liquid chromatography-mass spectrometry (LC-MS) analyses, where it corrects for matrix effects and instrument variability. This high-purity compound is essential for pharmaceutical R&D laboratories, clinical research facilities, and contract research organizations (CROs) focused on drug metabolism studies, pharmacokinetics, bioanalytical method development, and quality control.

Application

• Quantitative Bioanalysis: Serves as a critical internal standard for the precise quantification of Olanzapine in biological matrices (plasma, serum, urine) using LC-MS/MS.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug concentration over time in preclinical and clinical trials.
• Drug Metabolism and Disposition Research: Used in metabolite identification and profiling studies to understand the biotransformation pathways of Olanzapine.
• Forensic Toxicology: Supports accurate measurement of Olanzapine levels in forensic investigations and therapeutic drug monitoring (TDM).
• Method Development and Validation: A key component in developing, optimizing, and validating robust analytical methods according to FDA, EMA, or ICH guidelines.
• Quality Control & Stability Testing: Employed in pharmaceutical manufacturing for impurity profiling and assay of Olanzapine in active pharmaceutical ingredients (APIs) and finished dosage forms.

Basic Information

Product Name	Olanzapine-D8
CAS No.	1093380-13-2
Molecular Formula	C₁₇H₁₂D₈N₄S
Molecular Weight	312.48 g/mol
Synonyms	2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine-d8; LY 170053-d8; 2-Methyl-10-(4-methyl-1-piperazinyl)-4H-thieno[2,3-b][1,5]benzodiazepine-d8; Zyprexa-d8; Olanzapine (phenyl-d5, methyl-d3); Deuterated Olanzapine
EINECS	Contact for details

Quality Control

Every batch of Olanzapine-D8 is manufactured under strict quality management systems and undergoes comprehensive analytical testing to ensure identity, purity, and isotopic enrichment. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes data from NMR (¹H, ¹³C), mass spectrometry, and HPLC analysis. Our quality commitment aligns with the standards expected for high-purity reference standards in pharmaceutical analysis.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. For long-term storage, consider desiccant in the container.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Content)	≥ 98 atom % D
Chemical Purity (by NMR)	≥ 98.0%
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.