N-Desmethyl Olanzapine Hydrochloride | CAS 161696-76-0

Product Overview

N-Desmethyl Olanzapine Hydrochloride (CAS No. 161696-76-0) is a well-characterized pharmaceutical reference standard and research chemical widely used in bioanalytical, pharmacokinetic (PK), toxicological, and drug metabolism studies. It is the hydrochloride salt of N-Desmethyl Olanzapine, one of the major oxidative metabolites of Olanzapine, an atypical antipsychotic drug indicated for the treatment of schizophrenia and bipolar disorder.

This metabolite is primarily formed through N-demethylation, a metabolic pathway mediated mainly by CYP1A2, with minor contributions from other cytochrome P450 enzymes. Because it is one of the principal circulating metabolites of olanzapine, N-Desmethyl Olanzapine Hydrochloride is routinely used as an analytical reference standard during bioanalytical assay development, therapeutic drug monitoring (TDM), metabolite profiling, and pharmacokinetic investigations.

ResolveMass Laboratories Inc. supplies high-purity N-Desmethyl Olanzapine Hydrochloride for research, pharmaceutical development, quality control, forensic investigations, and regulatory analytical applications.

Chemical Properties

Structural Characteristics

N-Desmethyl Olanzapine Hydrochloride belongs to the thienobenzodiazepine class of heterocyclic compounds. Compared with the parent molecule (Olanzapine), it lacks one methyl group on the piperazine nitrogen, resulting from hepatic N-demethylation.

The hydrochloride salt offers improved stability and handling during analytical applications while maintaining excellent compatibility with chromatographic and mass spectrometric techniques.

Analytical Applications:

N-Desmethyl Olanzapine Hydrochloride is extensively used in pharmaceutical and bioanalytical laboratories for:

• LC-MS/MS method development
• LC-HRMS metabolite identification
• UHPLC-MS/MS quantitative analysis
• Pharmacokinetic studies
• Bioequivalence studies
• Drug metabolism investigations
• Therapeutic drug monitoring (TDM)
• Clinical pharmacology research
• Toxicokinetic studies
• Stability-indicating analytical methods
• Forensic toxicology
• Quality control laboratories

It serves as an authentic analytical standard for accurate identification and quantification of N-Desmethyl Olanzapine in biological matrices including plasma, serum, urine, cerebrospinal fluid, and tissue samples.

Importance in Drug Metabolism Studies

Understanding the metabolic fate of pharmaceutical compounds is essential for drug development and regulatory submissions. N-Desmethyl Olanzapine is among the primary metabolites formed following oral administration of olanzapine and is frequently monitored during:

• ADME studies
• Human pharmacokinetic studies
• Animal metabolism studies
• CYP450 enzyme investigations
• Drug-drug interaction studies
• Metabolite exposure assessments
• Metabolic pathway elucidation

The availability of a certified reference standard improves confidence in metabolite identification and quantitative analysis.

Bioanalytical Method Development

Highly sensitive bioanalytical assays require authentic metabolite standards for calibration and validation. N-Desmethyl Olanzapine Hydrochloride is suitable for use in accordance with FDA, EMA, and ICH bioanalytical method validation guidelines.

Common analytical platforms include:

• Triple Quadrupole LC-MS/MS
• UHPLC-MS/MS
• Orbitrap HRMS
• QTOF-MS
• HPLC-UV
• LC-QqQ systems

Typical validation studies include:

• Calibration curve preparation
• Accuracy and precision
• Recovery studies
• Matrix effect evaluation
• Dilution integrity
• Stability testing
• Limit of quantification (LLOQ)
• Selectivity and specificity

Pharmaceutical Research Applications

Researchers utilize N-Desmethyl Olanzapine Hydrochloride in numerous pharmaceutical development programs, including:

• Generic drug development
• Bioequivalence testing
• Clinical research
• Preclinical pharmacology
• Drug metabolism studies
• Biomarker research
• Toxicology investigations
• Therapeutic drug monitoring
• Regulatory submissions
• Reference standard qualification

Instrument Compatibility

This reference standard is compatible with various analytical instruments including:

• LC-MS/MS
• LC-QTOF
• Orbitrap HRMS
• UPLC-MS
• HPLC
• UHPLC
• Tandem Mass Spectrometry
• High-Resolution Mass Spectrometry (HRMS)

Quality Assurance

ResolveMass Laboratories Inc. supplies N-Desmethyl Olanzapine Hydrochloride with comprehensive analytical characterization. Depending on the product batch, documentation may include:

• Certificate of Analysis (CoA)
• HPLC Purity Report
• LC-MS Identity Confirmation
• Molecular Formula Verification
• Batch Number and Traceability
• Storage Recommendations

Each batch undergoes stringent quality control to ensure consistency, identity, and suitability for analytical research.

Why Choose ResolveMass Laboratories Inc.?

ResolveMass Laboratories Inc. is a trusted partner for pharmaceutical companies, CROs, academic institutions, and research laboratories requiring high-quality analytical reference standards. Our expertise in pharmaceutical analysis, mass spectrometry, and regulatory science enables us to provide reliable products that support drug development and compliance.

We offer:

• High-purity pharmaceutical reference standards
• Advanced LC-MS/MS and HRMS analytical expertise
• Batch-to-batch consistency
• Comprehensive analytical documentation
• Technical support from experienced scientists
• Solutions tailored for pharmaceutical R&D and quality control

Whether you are developing bioanalytical assays, conducting metabolite identification studies, or supporting regulatory submissions, ResolveMass Laboratories provides dependable reference materials to advance your research.

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