Description

Olanzapine Thiolactam Impurity is a critical pharmaceutical reference standard used in the analytical development and quality control of Olanzapine, an atypical antipsychotic medication. This compound is essential for identifying, quantifying, and monitoring the presence of this specific process-related impurity during drug manufacturing, ensuring final product safety and efficacy. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in method validation, stability studies, and regulatory compliance for Olanzapine API and finished dosage forms.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the accurate identification of Olanzapine Thiolactam in active pharmaceutical ingredient (API) batches.
• Analytical Method Development and Validation: Used as a system suitability standard to develop and validate HPLC, UPLC, or GC methods for impurity detection in Olanzapine.
• Quality Control and Release Testing: Employed in routine QC laboratories to quantify impurity levels against established ICH guidelines, ensuring batch-to-batch consistency.
• Stability Studies: Monitors the formation and growth of this impurity over time under various stress conditions (e.g., heat, humidity, light) to determine drug product shelf-life.
• Regulatory Submission and Compliance: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Used in synthetic chemistry R&D to study reaction pathways and optimize processes to minimize the formation of this impurity.

Basic Information

Product Name	Olanzapine Thiolactam Impurity
CAS No.	1017241-36-9
Molecular Formula	C₁₇H₂₀N₄S
Molecular Weight	312.43 g/mol
Synonyms	2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine; Olanzapine Thiolactam; Olanzapine Impurity F (Thiolactam); Olanzapine EP Impurity F; Olanzapine Related Compound F; 10H-Thieno[2,3-b][1,5]benzodiazepine, 2-methyl-4-(4-methyl-1-piperazinyl)-; Zyprexa Thiolactam Impurity
EINECS	Contact for details

Quality Control

Our Olanzapine Thiolactam Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) providing detailed results for identity, purity, and impurity profiles, typically assessed by HPLC, NMR, and MS. We support compliance with ICH Q3A/B, USP, and EP guidelines, and specifications can be aligned with client-specific pharmacopeial requirements.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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