Description

Olanzapine n-Formyl Impurity is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Olanzapine by enabling the accurate identification, quantification, and control of this specific process-related impurity. It is an essential tool for analytical chemists and quality assurance professionals working in pharmaceutical R&D, quality control laboratories, and regulatory affairs to meet stringent ICH guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of the n-Formyl impurity in Olanzapine API and finished drug products.
• Method Development and Validation: Crucial for developing and validating sensitive analytical methods, such as HPLC and LC-MS, to monitor impurity profiles.
• Quality Control and Batch Release: Used in routine QC testing to ensure Olanzapine batches comply with specified impurity limits as per pharmacopeial standards (USP, EP).
• Stability Studies: Employed to track the formation and level of this impurity during forced degradation and long-term stability studies of Olanzapine.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Process Chemistry Optimization: Aids chemists in refining synthetic and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Olanzapine n-Formyl Impurity
CAS No.	639460-79-0
Molecular Formula	C18H21N3O
Molecular Weight	295.38 g/mol
Synonyms	2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine-10-carbaldehyde; N-Formyl Olanzapine; Olanzapine N-Formyl Derivative; Olanzapine Impurity F (as per some sources); Olanzapine Related Compound F; 10H-Thieno[2,3-b][1,5]benzodiazepine-10-carboxaldehyde, 2-methyl-4-(4-methyl-1-piperazinyl)-; Olanzapine Carbaldehyde Impurity
EINECS	Contact for details

Quality Control

Every batch of Olanzapine n-Formyl Impurity is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, GC, NMR, and mass spectrometry to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all analytical results and confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines.

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 must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere in a desiccator.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown 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.