Description

Olanzapine n-Oxide is a key pharmaceutical intermediate and metabolite of the antipsychotic drug Olanzapine. This compound is of significant importance for research and development in neuropharmacology and for quality control in pharmaceutical manufacturing. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in drug metabolism studies, impurity profiling, and reference standard production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Olanzapine and its related substances in drug products and active pharmaceutical ingredients (APIs).
• Metabolite Research: Serves as a critical standard in pharmacokinetic and drug metabolism studies to understand the biotransformation pathways of Olanzapine.
• Impurity Profiling: Essential for analytical method development and validation to monitor and control process-related impurities and degradation products in Olanzapine API manufacturing.
• Bioanalytical Applications: Employed in the calibration of LC-MS/MS and HPLC systems for the accurate bioanalysis of Olanzapine and its metabolites in biological matrices.
• Pharmacology Studies: Used in preclinical research to investigate the activity, toxicity, and clearance mechanisms of Olanzapine metabolites.
• Quality Assurance & Control (QA/QC): A vital component in the quality control laboratories of API manufacturers and finished dosage form producers to ensure compliance with pharmacopeial standards (e.g., USP, EP).

Basic Information

Item	Detail
Product Name	Olanzapine n-Oxide
CAS No.	174794-02-6
Molecular Formula	C₁₇H₂₀N₄O₂
Molecular Weight	312.37 g/mol
Synonyms	Olanzapine N-Oxide; 2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine 5-Oxide; LY 170153 N-Oxide; Olanzapine Impurity F (EP); Olanzapine Related Compound F (USP); Olanzapine Metabolite N-Oxide; 10H-Thieno[2,3-b][1,5]benzodiazepine, 2-methyl-4-(4-methyl-1-piperazinyl)-, 5-oxide
EINECS	Contact for details

Quality Control

Our Olanzapine n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, residual solvent analysis, and identity confirmation (IR, NMR, MS) to ensure it meets the stringent requirements for use as a reference standard. Certificates of Analysis (COA) with detailed chromatographic data are provided, supporting compliance with USP, EP, and ICH guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to maximize stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w
Assay (on dried basis)	98.0% - 102.0%

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