Description

Olanzapine Impurity C is a specified impurity and degradation product of the antipsychotic drug Olanzapine. It is a critical reference standard used in pharmaceutical research, development, and quality control to ensure drug safety and efficacy. This compound is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who are responsible for method validation, stability studies, and monitoring impurity profiles in active pharmaceutical ingredients (APIs) and finished drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Olanzapine API and formulations.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Stability Indicating Studies: Employed in forced degradation studies to understand the degradation pathways of Olanzapine and to establish stability-indicating methods.
• Quality Control & Batch Release: Critical for setting specification limits and for the routine testing of Olanzapine batches to ensure compliance with ICH, USP, and EP guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Pharmacopoeial Testing: Used as a system suitability component in testing procedures as per United States Pharmacopeia (USP) and European Pharmacopoeia (Ph. Eur.) monographs.

Basic Information

Item	Details
Product Name	Olanzapine Impurity C
CAS No.	719300-59-1
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 Impurity 3; Olanzapine Related Compound C; 10H-Thieno[2,3-b][1,5]benzodiazepine, 2-methyl-4-(4-methyl-1-piperazinyl)-; Olanzapine N-Oxide Impurity; Zyprexa Impurity C
EINECS	Contact for details

Quality Control

Every batch of Olanzapine Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques like HPLC, GC, and NMR to ensure compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is 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. For long-term storage, consider storing at 2-8°C. The material is hygroscopic (moisture-sensitive) and should be handled in a dry atmosphere 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)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
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.