Description

Olanzapine Lactam Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of the antipsychotic drug Olanzapine. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of process-related substances. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers focused on method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for identifying and quantifying the lactam-related impurity in Olanzapine active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity detection in compliance with ICH guidelines.
• Quality Control and Batch Release Testing: Essential for routine QC testing in pharmaceutical manufacturing to ensure impurity levels are within specified limits as per pharmacopeial standards (USP, EP).
• Stability Studies and Forced Degradation Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the impurity profile.
• 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 Lactam Impurity
CAS No.	1017241-34-7
Molecular Formula	C17H20N4O
Molecular Weight	296.37 g/mol
Synonyms	2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepin-10-one; Olanzapine Lactam; Olanzapine EP Impurity G; Olanzapine USP Related Compound G; 10H-Thieno[2,3-b][1,5]benzodiazepin-10-one, 2-methyl-4-(4-methyl-1-piperazinyl)-; Olanzapine Degradant; Olanzapine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Olanzapine Lactam Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing purity, chromatographic data, and spectral confirmation is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material should be handled under inert conditions if specified to prevent degradation.

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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