Description

Loxapine Related Compound A (20 Mg) (3-Chloro-11-(4-Methylpiperazin-1-Yl)Dibenzo[B,F][1,4]Oxazepine) is a high-purity reference standard critical for pharmaceutical research and quality control. This compound is essential for the accurate identification, quantification, and monitoring of impurities in Loxapine drug substances and finished dosage forms. It is primarily used by analytical laboratories, quality assurance departments, and research institutions within the pharmaceutical and contract research organization (CRO) sectors to ensure product safety and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Control: Serves as a certified reference material (CRM) for the identification and quantification of specified impurities in Loxapine Active Pharmaceutical Ingredients (APIs) and formulations.
• Analytical Method Development and Validation: Used as a critical component in developing, optimizing, and validating HPLC, UPLC, or GC analytical methods for Loxapine.
• Stability Studies: Employed as a benchmark to track the formation of degradation products in Loxapine under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance and Documentation: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Quality Control (QC) Testing: Used in routine batch release testing of Loxapine to ensure impurity levels remain within International Council for Harmonisation (ICH) guidelines.
• Pharmacopoeial Standards: Acts as a working standard for tests specified in monographs from USP (United States Pharmacopeia), EP (European Pharmacopoeia), or other pharmacopoeias.

Basic Information

Product Name	Loxapine Related Compound A (20 Mg) (3-Chloro-11-(4-Methylpiperazin-1-Yl)Dibenzo[B,F][1,4]Oxazepine)
CAS No.	3454-96-4
Molecular Formula	C19H18ClN3O
Molecular Weight	339.82 g/mol
Synonyms	3-Chloro-11-(4-methyl-1-piperazinyl)dibenzo[b,f][1,4]oxazepine; Loxapine Impurity A; Loxapine Related Substance A; 7-Chloro-2-methyl-4H-benzo[b][1,4]benzoxazepin-4-one, 11-(4-methylpiperazinyl)-; DBZ 3454-96-4; Loxapine EP Impurity A; Loxapine USP Related Compound A
EINECS	Contact for details

Quality Control

Every batch of our Loxapine Related Compound A is manufactured and analyzed under strict quality management systems. The material undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced techniques like HPLC, GC-MS, and NMR to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This compound is hygroscopic (moisture-sensitive); ensure the container is sealed immediately after use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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