Description

Clozapine Impurity 9 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antipsychotic drug Clozapine. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development, quality control, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Clozapine Impurity 9 in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and LC-MS, to monitor impurities in Clozapine manufacturing.
• Quality Control (QC) Testing: Employed in routine QC laboratories to ensure Clozapine batches meet stringent pharmacopeial purity specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions to determine drug shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity profiling of Clozapine.
• Research and Development: Serves as a key material in pharmaceutical R&D for studying the metabolism, degradation pathways, and synthesis of Clozapine.

Basic Information

Product Name	Clozapine Impurity 9
CAS No.	63687-95-6
Molecular Formula	C18H19ClN4
Molecular Weight	326.82 g/mol
Synonyms	8-Chloro-11-(4-methylpiperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine; Clozapine Impurity C; Clozapine Related Compound C; 8-Chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine; Desmethylclozapine Impurity; Norclozapine Impurity; DBZP Impurity; LM 5008 Impurity
EINECS	Contact for details

Quality Control

Our Clozapine Impurity 9 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 supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We support compliance with ICH Q3A/B, USP, and EP 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 should be handled in a dry environment 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)	≤ 1.0%

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