Description

Clozapine Impurity 6 is a high-purity chemical 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 during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) units, and contract research organizations (CROs) for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling and Identification in Clozapine API and finished dosage forms.
• Analytical Method Development and Validation (HPLC, UPLC, LC-MS) for accurate quantification.
• Quality Control and Batch Release Testing to ensure drug product meets pharmacopeial standards (e.g., USP, EP).
• Stability Studies to monitor the formation of this impurity under various stress conditions.
• Regulatory Submissions (e.g., ANDA, NDA) to fulfill impurity characterization requirements for health authorities like the FDA and EMA.
• Research and Development of Clozapine synthesis pathways and degradation mechanisms.
• Calibration Standard for ensuring the accuracy and precision of analytical instruments.

Basic Information

Product Name	Clozapine Impurity 6
CAS No.	1025951-76-1
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 F; Clozapine Related Compound F; Clozapine EP Impurity F; Clozapine USP Impurity F; 5H-Dibenzo[b,e][1,4]diazepine, 8-chloro-11-(4-methyl-1-piperazinyl)-; DBZ 208
EINECS	Contact for details

Quality Control

Every batch of Clozapine Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment 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.

Specification

Item	Specification
Appearance	White to off-white solid
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 unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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