Description

5,10-Dihydro-2-Methyl-4H-Thieno[2,3-β][1,5]Benzodiazepin-4-One (Olanzapine Impurity) is a critical pharmaceutical reference standard used for the identification, qualification, and quantification of process-related impurities in Olanzapine drug substance and finished products. Its availability is essential for pharmaceutical manufacturers to ensure product safety, meet stringent regulatory requirements, and maintain batch-to-batch consistency. This high-purity compound is primarily required by quality control laboratories, analytical research & development teams, and regulatory affairs departments within the global pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Impurity Profiling and Control: Serves as a certified reference material (CRM) for the identification and quantification of this specific impurity during the development and manufacturing of Olanzapine API (Active Pharmaceutical Ingredient).
• Analytical Method Development and Validation: Used as a system suitability standard and for establishing detection/quantification limits in HPLC, UPLC, and LC-MS methods for Olanzapine.
• Regulatory Compliance and Submission: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed as a marker to monitor potential degradation pathways of Olanzapine under various stress conditions (forced degradation studies).
• Quality Control (QC) Testing: Acts as a primary standard in routine QC release testing of Olanzapine batches to ensure impurity levels remain within specified limits.
• Pharmacopoeial Standards: Supports compliance with monographs in pharmacopoeias such as USP, EP, and BP where control of specified impurities is mandated.

Basic Information

Product Name	5,10-Dihydro-2-Methyl-4H-Thieno[2,3-β][1,5]Benzodiazepin-4-One (Olanzapine Impurity)
CAS No.	221176-49-4
Molecular Formula	C₁₇H₁₄N₂OS
Molecular Weight	294.37 g/mol
Synonyms	Olanzapine Impurity; Olanzapine Related Compound; 2-Methyl-4H-thieno[2,3-b][1,5]benzodiazepin-4-one, 5,10-dihydro-; 5,10-Dihydro-2-methyl-4H-thieno[2,3-b][1,5]benzodiazepin-4-one; Thienobenzodiazepine derivative; Olanzapine Process Impurity; Olanzapine Degradant; Zyprexa Impurity
EINECS	Contact for details

Quality Control

Every batch of our 5,10-Dihydro-2-Methyl-4H-Thieno[2,3-β][1,5]Benzodiazepin-4-One is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including characterization by HPLC, GC, MS, NMR, and IR spectroscopy. Our products are designed to meet the rigorous standards of pharmaceutical impurity analysis. Certificates of Analysis (COA) with detailed chromatographic purity, assay results, and structural confirmation data are supplied with each shipment and are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The compound is light-sensitive (store away from light). For long-term storage, consider storing under inert atmosphere at lower temperatures (2-8°C) to ensure maximum 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 unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w
Assay (on dried basis)	97.0% - 103.0%

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